Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDreve Otoplastik GmbH
US
Last updated May 24, 2026
What Dreve Otoplastik GmbH makes
Dreve Otoplastik GmbH manufactures custom-made earmoulds, including impression kits for creating ear molds, as well as air-conduction hearing aid acoustic tubes. Their product line includes a range of earmould materials, such as Biopor® AB variants (including Xtreme, light, and fluorescent versions) and Fotoplast® S IO, designed for precision fitting and durability. Additional offerings include Otoform® Xpand, a material used for expanding ear impressions.
These devices are classified under Class I by regulatory standards and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates with a US presence, adhering to applicable medical device regulations in the country.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Dreve Otoplastik GmbH manufacture?
Dreve Otoplastik GmbH specializes in custom-made earmoulds and related accessories for hearing aid applications. Their product line includes custom earmoulds, kits for taking ear impressions, and air-conduction hearing aid acoustic tubes. Examples of their offerings are Biopor® AB materials (in various formulations like Xtreme, light, or fluorescent), Fotoplast® S IO, and Otoform® Xpand, which is used for expanding ear impressions during the moulding process. These devices are designed to fit individual patient anatomy precisely.
Where is Dreve Otoplastik GmbH based, and how does this affect its devices?
Dreve Otoplastik GmbH has a presence in the United States, meaning its devices are subject to FDA regulations. The company’s products are tailored to comply with US medical device standards, including classification under Class I, which typically applies to low-risk devices like custom earmoulds and impression kits. This classification reflects the minimal risk associated with these items when used as intended.
Which regulatory registries list Dreve Otoplastik GmbH’s devices?
Dreve Otoplastik GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify the identity and regulatory status of the company’s custom earmoulds, impression kits, and acoustic tubes. Listing in the UDI system is a requirement for Class I devices in the US to facilitate tracking and compliance.
How are Dreve Otoplastik GmbH’s devices classified under regulatory standards?
Dreve Otoplastik GmbH’s devices, including custom earmoulds, impression kits, and acoustic tubes, are classified as Class I under regulatory standards. This classification is based on their intended use—low-risk, non-invasive applications for fitting hearing aids—and the minimal potential harm they pose to patients when used correctly. Class I devices typically undergo less stringent premarket review but must still meet general safety and performance requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dreve.de
- —
- —
- [email protected]
- Phone
- +49230388070
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 315808340
Catalogue (527)
Page 1 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Biopor® AB | 28462M | FDA UDI | Class I | Active |
| Biopor® AB Xtreme | 288416 | FDA UDI | Class I | Active |
| Biopor® AB | 28412M | FDA UDI | Class I | Active |
| Biopor® AB RT Lack | 0834 | FDA UDI | Class I | Active |
| Fotoplast® S IO | 437 | FDA UDI | Class I | Active |
| Biopor® AB light | 28526 | FDA UDI | Class I | Active |
| Biopor® AB | 28303M | FDA UDI | Class I | Active |
| Biopor® AB | 28222M | FDA UDI | Class I | Active |
| Biopor® AB Xtreme | 28825M | FDA UDI | Class I | Active |
| Otoform® Xpand | 2966 | FDA UDI | Class I | Active |
| Biopor® AB fluoreszent | 28705 | FDA UDI | Class I | Active |
| Biopor® AB Xtreme | 288427 | FDA UDI | Class I | Active |
| Otoform® A softX | 8802ST | FDA UDI | Class I | Active |
| Small nylon tubing | 23010 | FDA UDI | Class I | Active |
| Otoform® A softX | 8801 | FDA UDI | Class I | Active |
| FotoTec® SL.E | 14110 | FDA UDI | Class I | Active |
| VarioTherm® Plus | 2300 | FDA UDI | Class I | Unknown |
| Biopor® AB Xtreme | 28861M | FDA UDI | Class I | Active |
| Biopor® AB | 28416M | FDA UDI | Class I | Active |
| Biopor® AB | 28415M | FDA UDI | Class I | Active |
| Biopor® AB | 282 | FDA UDI | Class I | Active |
| Pre-bent tubing | 04510 | FDA UDI | Class I | Active |
| T Mixing canulas | 3245 | FDA UDI | Class I | Active |
| FotoTec® DLP.A | 24640 | FDA UDI | Class I | Active |
| Mixing canulas | 3214 | FDA UDI | Class I | Active |
| Biopor® AB | 28492 | FDA UDI | Class I | Active |
| Fotoplast® S IO | 4824 | FDA UDI | Class I | Active |
| Biopor® AB Xtreme | 288258 | FDA UDI | Class I | Active |
| Biopor® AB light | 28593M | FDA UDI | Class I | Active |
| FotoTec® SL.A | 7400 | FDA UDI | Class I | Active |
| Biopor® AB monitoring | 28123M | FDA UDI | Class I | Unknown |
| Biopor® AB Xtreme | 288425 | FDA UDI | Class I | Active |
| Otoform® Ak | 452CNS | FDA UDI | Class I | Active |
| Biopor® AB Xtreme | 28826 | FDA UDI | Class I | Active |
| Biopor® AB Xtreme | 288632M | FDA UDI | Class I | Active |
| FotoTec® DLP.A | 24660 | FDA UDI | Class I | Active |
| Biopor® AB monitoring | 28122M | FDA UDI | Class I | Unknown |
| Biopor® AB Xtreme | 288430 | FDA UDI | Class I | Active |
| Thermosoft Lack | 4443 | FDA UDI | Class I | Active |
| Biopor® AB | 28433M | FDA UDI | Class I | Active |
| Fotoplast® Lack M | 49431 | FDA UDI | Class I | Active |
| Mixing canulas | 326 | FDA UDI | Class I | Active |
| Biopor® AB fluoreszent | 28703 | FDA UDI | Class I | Active |
| Biopor® AB | 28207 | FDA UDI | Class I | Active |
| Biopor® AB | 28362 | FDA UDI | Class I | Active |
| Biopor® AB Xtreme | 288420M | FDA UDI | Class I | Active |
| Biopor® AB | 28400 | FDA UDI | Class I | Active |
| Biopor® AB Xtreme | 288418 | FDA UDI | Class I | Active |
| Fotoplast® S hart | 43301 | FDA UDI | Class I | Active |
| FotoTec® SL.E | 14715 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Dreve Otoplastik GmbH UNNA North Rhine-Westphalia · DE FEI 3003610251