Identity
- Device Name
- Column Drape EUDAMED
- Model / Reference
- BTR08CC603 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00848340018909 EUDAMED
- Basic UDI-DI
- 84834000BTR08CC6036T EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Column Drape by Advance Medical Designs, Inc. — 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 | 84834000BTR08CC6036T | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advance Medical Designs, Inc.
- EUDAMED SRN
- US-MF-000009790
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 4bd34413-32bb-480d-b0ac-9c2a8f8af1d9 61 fields · synced Oct 6, 2026