Identity
- Trade Name
- R-100 Sterile Equipment Cover EUDAMED
- Device Name
- Sterile Drapes EUDAMED
- Model / Reference
- PBKBG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00845225012700 EUDAMED
- Basic UDI-DI
- B-00845225012700 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
R-100 Sterile Equipment Cover by Volcano Corporation — 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-00845225012700 | Class I | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (1)
- EUDAMED 114b2907-41f2-4042-b77d-5b62c99ec374 61 fields · synced Jun 19, 2026