Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033536319

FEI Number

3033536319

Entity Name

MEDI.PLAN GMBH & CO. KG

City/State/Country

Dortmund North Rhine-Westphalia, DE

Establishment Address

Hofkerstrabe 22, Dortmund North Rhine-Westphalia 44149, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MEDI.PLAN GmbH & Co. KG (Owner Number: 10091549)

Owner / Operator Contact Address

Hofkerstrabe 24, Dortmund, DE-NOTA 44149, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183399

PMA Number

N/A

All Registered Proprietary Names

MIXEVAC III, STERILE, CEMENT MIXER PACK 10 703418 Disposable Flow Transducers QTY 25 STETHOSCOPE COMFORT EAR TIPS, BLACK PAIR PACK 1 LUER ACTIVATED VALVE FOR IV ACCESS 0.25ML STERILE NON PYRO CASE 200 BD CATHETER TIP SYRINGE STERILE 50ML PACK 40 FLUID TRANSFER SET PVC VENTED SPIKE CASE 10 EXT SET, STD BORE M/LL 16CM CASE 48 ALLEVYN GENTLE BORDER LITE 15X15CM PACK 10 ALLEVYN GENTLE BORDER 10X10CM PACK 10 ALLEVYN ADH 12.5X12.5CM PACK 10 ALLEVYN NON ADH HEEL 10.5X13.5CM PACK 5 STOPCOCK 4WAY LARGE BORE W/MALE LL CASE 50 RECHARGABLE 3.5V BATTERY, BLACK PACK 1 ONE-LINK STD BORE CATH EXT SET CASE 200 SET EXTENSION ONE-LINK MICROBORE CASE 200 STRAIGHT-TYPE EXTENSION SET, MICROBORE, ONELINK NEEDLE FREE CONNECTOR CASE 200 CONNECTOR IV ONE-LINK NEEDLE-FREE CASE 200 PORT PROTECTOR LUER LOCK DUAL CASE 504 FLEXIPORT BP CUFF REUSABLE 2TB 25-34CM, ADULT PACK 1 FLEXIPORT BP CUFF REUSABLE, SMALL INFANT PACK 1 FLEXIPORT BP CUFF REUSABLE, SMALL ADULT PACK 1 COILED TUBING 8FT, PACK 1 FLEXIPORT BP CUFF REUSABLE 25-34CM, LONG ADULT PACK 1 FLEXIPORT BP CUFF SINGLE USE, ADULT REGULAR PACK 20 FLEXIPORT BP CUFF REUSABLE 1TB 25-34CM, LONG ADULT PACK 1 FLEXIPORT BP CUFF REUSABLE 25-34CM, ADULT PACK 1 FLEXIPORT BP CUFF REUSABLE 1TB, SMALL ADULT PACK 1 FLEXIPORT BP CUFF SINGLE USE, ADULT LONG PACK 20 FLEXIPORT BP CUFF REUSABLE, INFANT PACK 1 FLEXIPORT BP CUFF REUSABLE 2TB, SMALL ADULT PACK 1 MEPIFORM STERIL 4X30CM PACK 5 MEPIFORM 10 X 18 CM PACK 5 MEPIFORM STERIL 5X7.5CM PACK 5 CONTAINER FLUID NON-DEHP 250M CASE 48 BULKTUBE URINALYSIS 8ML 16X100ML W/YLW PACK 100 RAPIDFILL CONNECTORS - RED CASE 50 HALOGEN LAMP 3.5V PACK 6 HALOGEN LAMP BULB 4.6V PACK 6 HALOGEN LAMP BULB 3.5V PACK 6 DIAGNOSTIC LAMP BULB 3.5V PACK 1 HALOGEN LAMP 2.5V PACK 6 BD SAFETYGLIDE SYRINGE 1ML 27GX1/2" TUBERCULIN PACK 100 IRRIGATION SET CYSTO W/LG BORE CLAM CASE 48 Y-TYPE TUR-BLADDER IRRIGATION CASE 12 SET BASIC TPN 10 CASE 48 CLEARLINK PACLITAXEL SET CASE 48 ACTIVELIFE ONE-PIECE DRAINABLE POUCH PACK 10 PRIMAPORE 7.5X5CM PACK 100 OPSITE FLEXIGRID 6X7CM PACK 100 OPSITE 9.5X8.5CM PACK 20 OPSITE 15.5X8.5CM PACK 20 PRIMAPORE 10X8CM PACK 20 OPSITE IV 3000 6X7CM PACK 100 OPSITE 25X10CM PACK 20 PRIMAPORE 20X10CM PACK 20 OPSITE FLEXIGRID 15X20CM PACK 10 OPSITE 6.5X5CM PACK 100 OPSITE FLEXIFIX 10CMX10M PACK 1 IV 3000 OPSITE 10CM X 12CM PACK 50 PRIMAPORE 15X8CM PACK 20 OPSITE FLEXIFIX 5CMX10M PACK 1 DURASHOCK DS58 FAMILY KIT PACK 1 DURASHOCK ONE PIECE BLOOD PRESSURE CUFF ADULT PACK 1 ANEROID WALL MOUNT W/ADULT CUFF, PACK 1 ADULT ANEROID ONE PIECE WITH CUFF PACK 1 FLEXIPORT BP CUFF REUSABLE, ADULT PACK 1 FLEXIPORT BP CUFF ONE PIECE, CHILD PACK 1 KLEENSPEC EAR SPECULUM DISPENSER W/STORAGE, PACK 10 FILTER BLOOD CASE 48 OTOSCOPE HEAD LED MACROVIEW, PACK 1 OTOSCOPE MACROVIEW 3.5V HALOGEN BULB, PACK 1 OTOSCOPE REUSABLE EAR SPECULUM 5MM, PACK 1 OTOSCOPE UNIVERSAL POLY REUSABLE EAR SPECULUM 3MM, PACK 1 OTOSCOPE UNIVERSAL POLY REUSABLE EAR SPECULUM 4MM, PACK 1 EAR TIPS FOR 29350, PACK 25 OTOSCOPE REUSABLE EAR SPECULUM 3MM, PACK 1 OTOSCOPE WALL TRANSFORMER HANDLE, PACK 1 OTOSCOPE SPECULA DISPENSER PACK 10 OTOSCOPE JUNIOR SET W/HANDLE AND CASE PACK 1 OTOSCOPE INSUFFLATION BULB PACK 1 OTOSCOPE MACROVIEW 3.5V PACK 1 RECHARGABLE HANDLE PLUG IN PACK 1 JUNIOR POCKETSCOPE SET PACK 1 EAR SPECULUM SET, PACK 4 OTOSCOPE REUSABLE EAR SPECULUM 4MM, PACK 1 OTOSCOPE UNIVERSAL POLY REUSABLE EAR SPECULUM 5MM, PACK 1 BD SYRINGE 1ML LUER-LOCK PACK 100 BD ECLIPSE SYRINGE 3ML 23GX1 PACK 50 BD ECLIPSE SYRINGE 3ML 25GX5/8" PACK 50 OPHTHALMOSCOPE 3.5V CONTINU-FLO SOLUTION SET, M/LL, NON-VNTD SPIKE, CLEARLINK CASE 48 BD CATHETER TIP SYRINGE STERILE 50ML PACK 40 CONTINU-FLO DROP SET 60 DROP 8 CM CASE 48 WATER TRAP, WATERLOCK 2 PACK 12 DIAGNOSTIC WALL SYSTEM (GREEN) PACK 1 SOLUTION SET, M/LL, 2 INTERLINK INJ SITES CASE 48 BD VACUTAINER LUER-LOK ACCESS DEVICE PACK 198 ACTICOAT FLEX 3 10X10CM PACK 12 SURETEMP WALL MOUNT HOLDER PACK 1 SURETEMP PLUS 690 THERMOMETER W/9' PROBE PACK 1 OPHTHALMOSCOPE 3.5V PACK 1 BD NEXIVA CLOSED IV CATHETER SINGLE PORT 18GX1.25" PACK 20 BD NEXIVA CLOSED IV CATHETER SINGLE PORT 20GX1" PACK 20 BD NEXIVA CLOSED IV CATHETER SINGLE PORT 22GX1" PACK 20 BD NEXIVA CLOSED IV CATHETER SINGLE PORT 24GX3/4" PACK 20

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2025-06-03
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-11-13
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2024-10-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-08-12
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2025-07-14
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2025-06-03
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2025-06-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2024-10-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2025-06-03
HKM	Retinoscope, Battery-Powered	Ophthalmic	Class 1	886.1780	2025-03-06
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2025-06-03
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-10-14
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2025-06-04
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2025-03-06
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-08-12
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2024-10-14
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2025-03-06
LJH	System, Irrigation, Urological	Gastroenterology, Urology	Class 2	876.5130	2025-06-03
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-06-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
EXH	Bag, Urinary, Ileostomy	Gastroenterology, Urology	Class 1	876.5900	2024-10-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2024-10-14
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-10-14
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2025-06-03
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2025-06-04
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2024-10-14
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-03-06
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2024-10-21
HLI	Ophthalmoscope, Ac-Powered	Ophthalmic	Class 2	886.1570	2024-10-21
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2026-03-23
HLS	Exophthalmometer	Ophthalmic	Class 1	886.1270	2024-10-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-06-03
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-03-06
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2024-10-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-10-14
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2024-10-14
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-03-10

Official Correspondent

Amela Karic

US Agent Details

Lisa Capote Business: Capote Law Firm Email: lisa@capotelawfirm.com Phone: (786) 8715680

Related Public Records

Same Entity

MEDI.PLAN GmbH & Co. KG

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
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033536319. Last updated year: 2026. Please use registration number 3033536319 when referencing this establishment in official correspondence.