Identity
- Trade Name
- OP-G7+ GOEPEL EUDAMEDOptomic FDA UDI
- Generic Name
- General examination/treatment chair, electric FDA UDI
- Device Name
- Chair EUDAMED
- Model / Reference
- 68303049 EUDAMEDOP-G7+ CHAIR (GOEPEL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08436041580461 EUDAMEDFDA UDI
- Basic UDI-DI
- 84360415810322M EUDAMED
- FDA Product Code
- GBB FDA UDI
- EMDN Code
- V08020101 GENERIC USE ELECTRIC MEDICAL CHAIRS EUDAMED
- GMDN Term
- General examination/treatment chair, electric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 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: General examination/treatment chair, electric
Optomic by Optomic España Sa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 d224b776-3a4f-4dbe-9f2a-c0211a233c7f 32 fields · synced Sep 18, 2026
- EUDAMED 9b7e2c4a-6d3d-4c17-b1af-342aafe87983 61 fields · synced Sep 18, 2026