Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010155

FEI Number

4476

Entity Name

A.HANDTE MEDIZINTECHNIK GMBH & CO. KG

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

EHRENBERGSTRASSE 39, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

A.HANDTE MEDIZINTECHNIK GMBH & CO. KG (Owner Number: 8010155)

Owner / Operator Contact Address

EHRENBERGSTRASSE 39, --, TUTTLINGEN, DE-NOTA D-78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WELLAMINSKI ANTRUM PERFO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKE	Curette, Operative	Dental	Class 1	872.4565	1978-03-22
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	1978-03-22
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2018-07-25
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	1978-03-22
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	1978-03-22
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	1978-03-22
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2002-07-24
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1978-03-22
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	1978-03-22
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1978-03-22
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1978-03-22
GWY	Pinwheel	Neurology	Class 1	882.1750	1978-03-22
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	1978-03-22
KAT	Perforator, Antrum	Ear, Nose, Throat	Class 1	874.4420	2002-07-24
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1978-03-22
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1978-03-22
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	1978-03-22
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1978-03-22
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	1997-11-24
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	Class 1	878.4800	1978-03-22
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	1978-03-22
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	1978-03-22
EIG	Retractor, All Types	Dental	Class 1	872.4565	1978-03-22
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	1978-03-22
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	1978-03-22
KBP	Hook, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
JYI	Gauge, Mastoid	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	1978-03-22
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	1978-03-22
HWA	Impactor	Orthopedic	Class 1	888.4540	1978-03-22
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	1978-03-22
KBH	Adenotome	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1978-03-22
KAZ	Rasp, Frontal-Sinus	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1978-03-22
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	1978-03-22
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	1997-11-24

Official Correspondent

Philip HANDTE

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

A.HANDTE MEDIZINTECHNIK 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
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K894785	Fdt Precision Machine Co., Inc.	SURGICAL CHISEL/OSTEOTOME	1989-08-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0010-2008	N/A	1	EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

Similar Registrations

Registration Number	Establishment Name	Location
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
8010159	A. SCHWEICKHARDT GMBH & CO. KG	Seitingen-Oberflacht Baden-Wurttemberg, DE
2431166	Sklar Corporation	West Chester, PA, US
3009171220	DENTIMED SAO JOAO	Sunrise, FL, US
3017352116	LACIGRUS INTERNATIONAL	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010155. Last updated year: 2026. Please use registration number 8010155 when referencing this establishment in official correspondence.