Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010730

FEI Number

7252

Entity Name

ALBERT HOHLKOERPER GMBH & CO. KG

City/State/Country

HEMER North Rhine-Westphalia, DE

Establishment Address

MAERKISCHE STR. 35, HEMER North Rhine-Westphalia 58675, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ALBERT HOHLKOERPER GMBH & CO. KG (Owner Number: 8010731)

Owner / Operator Contact Address

MAERKISCHE STR. 35, --, HEMER, DE-NW 58675, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SANITY Sanity SANITY SANITY SANITY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGY	Pump, Breast, Non-Powered	Obstetrics/Gynecology	Class 1	884.5150	2009-05-19
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2014-01-24
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2014-01-24
FCE	Enema Kit	Gastroenterology, Urology	Class 1	876.5210	2009-05-19
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2009-05-19
HED	Douche Apparatus, Vaginal, Therapeutic	Obstetrics/Gynecology	Class 1	884.5900	2009-05-19
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2018-10-17

Official Correspondent

RUDOLF ALBERT

US Agent Details

Teresa Miklas Business: Albert International Inc. Email: tmiklas@albertusa.com Phone: (770) 2877424

Related Public Records

Same Entity

ALBERT HOHLKOERPER 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010730. Last updated year: 2026. Please use registration number 8010730 when referencing this establishment in official correspondence.