Identity
- Trade Name
- BASIC PLUS EUDAMEDOTOPRONT FDA UDI
- Generic Name
- ENT examination/treatment system FDA UDI
- Device Name
- ENT Treatment Unit EUDAMED
- Model / Reference
- BASIC PLUS EUDAMEDFDA UDI250090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260154541606 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260154541606 EUDAMED
- FDA Product Code
- ETF FDA UDI
- EMDN Code
- Z121402 ENT TREATMENT UNITS EUDAMED
- GMDN Term
- ENT examination/treatment system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.5300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as ENT examination/treatment system.
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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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Happersberger Otopront GmbH
Sources (2)
- FDA UDI 79ccbd47-a1db-49b8-8a57-e6f50af7f2e3 32 fields · synced Jul 25, 2026
- EUDAMED 252085c0-edd3-4685-9eb1-888565c294db 61 fields · synced Jul 25, 2026