Identity
- Trade Name
- SurgiTel EUDAMEDFDA UDI
- Generic Name
- Surgical binoculars, reusable FDA UDI
- Device Name
- SurgiTel EUDAMEDOptical assembly and light source for magnified view and more ergonomic posture for surgical and dental procedures. FDA UDI
- Model / Reference
- FLM Loupe, Wired Light EUDAMEDFDA UDI
- Description
- Optical assembly and light source for magnified view and more ergonomic posture for surgical and dental procedures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810114911082 EUDAMEDFDA UDI
- Basic UDI-DI
- 081011491Magnification6C EUDAMED
- Direct Marketing DI
- 00810114911082 EUDAMED
- FDA Product Code
- HOH FDA UDI
- EMDN Code
- Y210399 OPTICAL AIDS - OTHER EUDAMED
- GMDN Term
- Surgical binoculars, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4770 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
SurgiTel by General Scientific Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081011491Magnification6C | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- General Scientific Corporation
- EUDAMED SRN
- US-MF-000038902
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (3)
- EUDAMED c76f8ccb-0d9d-43ed-8b45-32588a339f26 61 fields · synced Jul 24, 2026
- FDA UDI ebffc31c-ca6c-41c3-bee7-561da4400f2d 33 fields · synced May 30, 2026
- EUDAMED c76f8ccb-0d9d-43ed-8b45-32588a339f26-1 61 fields · synced Jun 10, 2026