Identity
- Trade Name
- OTOPRONT FDA UDI
- Generic Name
- ENT examination/treatment system FDA UDI
- Model / Reference
- BASIC PLUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260154541026 FDA UDI
- FDA Product Code
- ETF FDA UDI
- GMDN Term
- ENT examination/treatment system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5300 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: ENT examination/treatment system
Otopront by Happersberger Otopront GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Optomic — OPTOMIC ESPAÑA SA · Class I
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- Extension module, 1 handle, ri-former® — Rudolf Riester GmbH & Co. KG · Class II
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
- Happersberger Otopront GmbH
Sources (1)
- FDA UDI 3d781e73-2bcd-45ce-9e42-4daaa8aaa50f 32 fields · synced Jun 1, 2026