Identity
- Trade Name
- BTX Surg EUDAMED
- Device Name
- Ophthalmic Sponge EUDAMED
- Model / Reference
- WI0001Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711552924862 EUDAMED
- Basic UDI-DI
- 471155292OPT6 EUDAMED
- Direct Marketing DI
- 04711552924862 EUDAMED
- EMDN Code
- M040399 OPHTHALMIC DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
BTX Surg by Cenefom Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471155292OPT6 | Class I | Active |
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Manufacturer
- Manufacturer
- Cenefom Corp.
- EUDAMED SRN
- TW-MF-000012190
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED fe228485-39da-40c7-afb5-051b6196559f 61 fields · synced Jul 27, 2026