Identity
- Trade Name
- OTOSMART COMPACT EUDAMEDOptomic FDA UDI
- Generic Name
- ENT examination/treatment system FDA UDI
- Device Name
- Workstaion type B EUDAMED
- Model / Reference
- 67633035 EUDAMEDOTOSMART COMPACT WORKSTATION FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436041581147 EUDAMEDFDA UDI
- Basic UDI-DI
- 843604158133438 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
- 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
Category: ENT examination/treatment system
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 ENT examination/treatment system.
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- Extension module, 1 handle, ri-former® — Rudolf Riester GmbH & Co. KG · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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 36620520-4644-49a5-a114-2e073aeb343b 32 fields · synced Jun 18, 2026
- EUDAMED 5270c99a-639b-4ad2-a84b-da59c3bde710 61 fields · synced Jun 18, 2026