Identity
- Trade Name
- OPT Ø2,7mm x 75mm x 70º AUT. EUDAMEDOptomic FDA UDI
- Generic Name
- Otoscope, endoscopic FDA UDI
- Device Name
- RIGID ENDOSCOPE-OTOSCOPE EUDAMED
- Model / Reference
- 38263440 EUDAMEDOTOSCOPE OPT 2,7mm x 75mm x 70 AUT. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436041580591 EUDAMEDFDA UDI
- Basic UDI-DI
- 84360415816413L EUDAMED
- Direct Marketing DI
- 08436041580591 EUDAMED
- FDA Product Code
- ERA FDA UDI
- EMDN Code
- Z12021007 MIDDLE EAR OTOSCOPES EUDAMED
- GMDN Term
- Otoscope, endoscopic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4770 FDA UDI
- Market of Registration
- Spain 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Otoscope, endoscopic
Optomic by Optomic España Sa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Otoscope, endoscopic.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Optomic España Sa
Sources (2)
- FDA UDI f43da2b9-c9c9-4440-aa8c-bef47e055d77 32 fields · synced Jul 20, 2026
- EUDAMED 7a17d327-03f5-4c99-a257-794322d5c30f 61 fields · synced Jul 20, 2026