Identity
- Trade Name
- Otoform® A soft FDA UDI
- Generic Name
- Earmould impression kit FDA UDI
- Device Name
- No. FDA UDI
- Model / Reference
- 3206M FDA UDI
- Description
- No. FDA UDI
Identifiers
- Catalog Number
- 3206M FDA UDI
- Primary DI / UDI-DI
- E2393206M1 FDA UDI
- FDA Product Code
- LDG FDA UDI
- GMDN Term
- Earmould impression kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Earmould impression kit
Otoform® A soft by Dreve Otoplastik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Earmould impression kit.
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- egger A/ITE vario — Innovation MediTech GmbH · Class I
- Soft Medial Mixing Tips — EARLENS CORPORATION · Class I
- impression plugs, conical — DETAX GmbH · Class I
- EZX — IMEDICOM CO., LTD. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dreve Otoplastik GmbH
Sources (1)
- FDA UDI a8872431-f159-4b23-8483-94bca7a6787b 36 fields · synced Jun 8, 2026