Dreve Otoplastik GmbH

FDA Device Registration & Listing · UNNA North Rhine-Westphalia, DE · Registration 3003610251

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003610251
FEI Number
3003610251
Entity Name
Dreve Otoplastik GmbH
City/State/Country
UNNA North Rhine-Westphalia, DE
Establishment Address
MAX-PLANCK-STR. 31, UNNA North Rhine-Westphalia 59423, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
DREVE OTOPLASTIK GMBH (Owner Number: 9028387)
Owner / Operator Contact Address
Max-Planck-Strasse 31, --, UNNA, DE-NW 59423, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Otoferm Creme

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2012-11-02
KMJ Lubricant, Patient General Hospital Class 1 880.6375 2021-02-11

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Nickoloff Business: DREVE AMERICA CORP. Email: Robert.Nickoloff@Dreve-America.com Phone: (651) 3249494

Related Public Records

Same Entity

DREVE OTOPLASTIK 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
K820587 Abco Dealers, Inc. WET PACK LINE OF PRODUCTS 1982-03-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003610251. Last updated year: 2026. Please use registration number 3003610251 when referencing this establishment in official correspondence.
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