Identity
- Trade Name
- Surgitrac EUDAMED
- Device Name
- Kratz Barraquer open loop wire speculum EUDAMED
- Model / Reference
- SC11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976939130405 EUDAMED
- Basic UDI-DI
- B-06976939130405 EUDAMED
- EMDN Code
- Q021106 OPHTHALMIC SURGERY DILATORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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 IIa — 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-06976939130405 | Class IIa | 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 0a2b12b3-57d6-4555-a440-13088173a4c6 61 fields · synced Jul 22, 2026