Identity
- Trade Name
- Surgitrac EUDAMED
- Device Name
- Lasik Flap elevator EUDAMED
- Model / Reference
- RUR31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976939132263 EUDAMED
- Basic UDI-DI
- B-06976939132263 EUDAMED
- EMDN Code
- L1711 OPHTHALMOLOGY HOOKS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Surgitrac by Sihong Surgitrac Co., Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06976939132263 | Class I | Active |
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Manufacturer
- Manufacturer
- Sihong Surgitrac Co., Ltd
- EUDAMED SRN
- CN-MF-000041149
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED ec9f336a-05e3-433d-b70b-b62bc4c792d0 61 fields · synced Jul 9, 2026