Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010704

FEI Number

3002807754

Entity Name

NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

WEILATTEN 7-9, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH (Owner Number: 8010704)

Owner / Operator Contact Address

WEILATTEN 7-9, --, TUTTLINGEN, DE-NOTA 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CURETTE SPREADER BLADDER INSTR SURGICAL CARDIO OTOSCOPE CLAMP FORCEPS BIOPSY GYN GAG MOUTH MATRIX RETAINER TUBE TONSIL SUCTION PUNCH TONSIL MARGIN TRIMMER KNIFE, ENT FORCEPS DRESSING DENTAL TAPE MEASURING RETRACTOR SPECULUM ENT BURNISHER KNIFE ORTHOPEDIC RONGEUR GAUGE MEASURING FORK TUNING RETRACTOR TRAY SURGICAL RASPATORY SURGICAL CHISEL BONE SYRINGE ENT FILE BONE SPATULA SURGICAL CARVER ELEVATOR ENT NEEDLE HOLDER SNARE SAW ELECTRIC BLADE SAW FORCEPS GENERAL HOE PUNCH NASAL CLAMP SURGICAL nopa CURETTE SCISSORS OPHTALMIC SCISSORS DISPO SPECULUM VAGINAL Marker Ophtalmic SAW MANUAL DPRESSOR TONGUE CARDIOVASCULAR INSTRUMENT ELEVATOR RETRACTOR ENT BRACE DRILL LIGHT EXAMINATION INSTRUMENT MANUAL CAST APPLICATION PLASTIC FILLING INSTRUMENT PROBE BURR SNARE SURGICAL ROACH CARVER LAB WIRE (MULTIPLE BRANDS) TWISTER TWISTER WIRE EXPLORER OPERATIVE FORCEPS ENT RING CUTTER ENT MIRROR OSTEOTOME MANUAL TROCAR ENT BLADE SCALPEL SPLINT NASAL Lead Hand SCISSORS GENERAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2006-01-11
FHK	Spreader, Bladder Neck	Gastroenterology, Urology	Class 1	876.4730	1997-07-25
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2009-10-01
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	1997-05-22
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2009-09-04
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	1984-10-30
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	1997-05-22
JEP	Retainer, Matrix	Dental	Class 1	872.4565	2004-06-08
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	1997-08-06
KBT	Punch, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1997-07-25
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2004-06-08
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	1998-03-31
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	1984-10-30
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1999-11-15
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1997-05-22
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	1997-05-15
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2004-06-08
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	1997-07-23
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	1984-10-30
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	1998-01-05
GWX	Fork, Tuning	Neurology	Class 1	882.1525	1997-07-25
EIG	Retractor, All Types	Dental	Class 1	872.4565	2004-06-08
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2008-07-02
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-08-06
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1997-05-22
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	1997-07-25
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	1997-07-23
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1984-10-30
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2004-06-08
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2009-10-01
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	1984-10-30
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1997-07-25
DWI	Saw, Electrically Powered	General, Plastic Surgery	Class 1	878.4820	1998-01-28
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	1984-10-30
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1984-10-30
EMQ	Hoe, Periodontic	Dental	Class 1	872.4565	2004-06-08
KAY	Punch, Nasal	Ear, Nose, Throat	Class 1	874.4420	1997-05-22
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-22
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2008-06-12
EKT	Curette, Endodontic	Dental	Class 1	872.4565	2004-06-08
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	1997-05-28
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	1984-08-21
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	1997-05-22
HMR	Marker, Ocular	Ophthalmic	Class 1	886.4570	2014-02-20
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	1997-05-22
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1997-05-22
FZR	Contractor, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-03-27
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1997-05-22
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	1997-07-25
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	1997-05-15
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2008-07-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1997-05-22
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	1997-05-12
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2004-06-10
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2009-10-01
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	1997-05-22
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-05-22
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2004-06-08
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2002-04-19
EKB	Explorer, Operative	Dental	Class 1	872.4565	2004-06-08
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	1997-07-25
FNS	Ring Cutter	General Hospital	Class 1	880.6200	1997-07-25
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	1997-07-23
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	1997-05-12
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	1997-08-12
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	1984-10-30
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	1997-08-21
EAJ	Apron, Leaded	Radiology	Class 1	892.6500	2014-02-24
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	1997-06-25

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH

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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010704. Last updated year: 2026. Please use registration number 8010704 when referencing this establishment in official correspondence.