Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004749705

FEI Number

3004749705

Entity Name

M.D.L. S.R.L.

City/State/Country

Delebio (So) Sondrio, IT

Establishment Address

Via Tavani 1/a, Delebio (So) Sondrio 23014, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

M.D.L. S.r.l. (Owner Number: 10047695)

Owner / Operator Contact Address

Via Tavani 1/a, Delebio (So), IT-SO 23014, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FASTCUT P Disposable needle XXGxYYYmm for soft tissue biopsy compatible automatic Promag Gun EASYLOCK Modified Menghini needle, XXGxYYYmm for aspirated cytohistological biopsy FAST-CUT E Disposable needle XXGYYYmm for soft tissue biopsy compatible with automatic Promag 2.2 gun INTRO Coaxial introducer needle XXG for needles XXG FASTCUTS Disposable needle XXGxYYYmm for soft tissue biopsy, compatible with automatic Sterylab Fastgun Gun PALIUM NEEDLE Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium FASTCUTM Disposable needle XXGxYYYmm for soft tissue biopsy compatible with Magnum Gun Bard HANDCUT Disposable needle XXGxYYYmm for soft tissue biopsy with manual action PALIUM COAXIAL Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium with coaxial XXGxYYmm FAST-CUT E Disp. needle XXGxYYYmm for soft tissue biopsy compatible with automatic Promag 2.2. gun with coaxial XXGxYYmm THEMY Automatic needle XXGxYYYmm for soft tissue biopsy. Notch 20mm SEMICUT Semiautomatic guillotine needle XXGxYYYmm for soft tissues biopsy without removable Luer INTRO Coaxial introducer needle XXG for needles XXG PALIUM NEEDLE Guillotine needle XXGxYYYmm soft tissue biopsy, Magnum Gun Bard and Palium Palium Automatic reusable gun for soft tissue biopsy EASYCUT Semiautomatic needle XXGxYYYmm for cytohistological biopsy by aspiration as for Menghini modified MARKSLIM Not repositionable needle XXGxYYYmm for mammary nodules localization, slimline, single hook REPOMARK Repositionable needle, homertype XXGxYYYmm for mammary nodules localization, single hook MARK Not repositionable disposable needle XXGxYYYmm for mammary nodule localization with single hook AUTOMARK Semiautomatic not repositionable needle XXGxYYYmm for mammary nodules localization, single hook MARKX Not repositionable disposable needle XXGxYYYmm for mammary nodule localization with double hook PEN-BONE Dispos. bone marrow biopsy needle for iliac crest marrow aspiration, light version XXGxYY/ZZmm OSTEOJ Disposable bone marrow biopsy needle with extraction wire and safety XXGxYYYmm HARVEST Disposable biopsy needle for bone marrow transplantation with "T" handle XXGxYYYmm PRESSTO Needle for bone biopsy with internal catching system and ergonomic handle, XXGxYYYmm ILLY Disposable needle for iliac crest marrow aspiration, "T" handle XXGxYY/ZZmm PICKUP Needle for bone biopsy XXGxYYYmm with external catching system, wire extraction JAMBLU Bone marrow biopsy needle light version with extraction wire XXGxYYYmm Bone-HarvestOR - Autologous bone harvesting system Cell-HarvestOR - Multiradial selective harvesting system of autologous bone marrow CYTOCUT Disposable chiba needle XXGxYYYmm for aspirated cyto-histological biopsy PneumoDart Liposuction cannula LP25180111, LP0907119, LP1718123

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJG	Device, Percutaneous, Biopsy	General, Plastic Surgery	Class 1	878.4800	2015-10-05
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2016-12-27
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-12-27
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-10-05
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2014-10-21
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2015-10-05
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-05-28
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2023-02-07

Official Correspondent

Marcello Dell 'Oca

US Agent Details

Valerie Followell Business: Followell Compliance Consultants LLC Email: valeriefollowell@outlook.com Phone: (847) 4006187

Related Public Records

Same Entity

M.D.L. S.r.l.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150891	Covidien, LLC( Formerly Beacon Endoscopic Corp.)	BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System	2015-05-01
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K863293	Lifestream Int'L, Inc.	DISPOSABLE SUCTION CANNULA NO. 902008-000	1986-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2011	Medical Device Technologies, Inc.	1	Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows: Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M. Model Number: 763114160X Lot #'s 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ. Model Number: 763114200X Lot #'s 92661WY0, 00751ZYJ, 012420U1 Model Number: 763116100X Lot #'s 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3. Model Number: 763116160X Lot #'s 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS Model Number: 763116200X Lot #'s 121KN Model Number: 763116200X Lot #'s 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT Model Number: 763118100X Lot #'s 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX. Model Number: 763118160X Lot #s 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO. Model Number: 763118200X Lot #s 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I. Model Number: 763120100X Lot #s 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF. Model Number: 763120160X Lot #s 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8. Model Number: 763120200X Lot #s 00351Z85, 012020QG, 012420TW. Model Number: 763418200X Lot #s 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6. Model Number: 763418250X Lot #s 92751X60, 00671ZRL, Model Number: 763418250X Lot #s 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004749705. Last updated year: 2026. Please use registration number 3004749705 when referencing this establishment in official correspondence.