Identity
- Trade Name
- C-Arm Drape EUDAMED
- Device Name
- C-Arm Drape EUDAMED
- Model / Reference
- E6020N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975085708247 EUDAMED
- Basic UDI-DI
- 697508570EC04J7 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
C-Arm Drape by Exact Medical Manufacturing, 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 | 697508570EC04J7 | Class I | Active |
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Manufacturer
- Manufacturer
- Exact Medical Manufacturing, Inc
- EUDAMED SRN
- CN-MF-000001406
- Authorised Representative
- Exact Medical Manufacturing B.V. NL-AR-000000452
Sources (1)
- EUDAMED fe7f9f89-8cd3-4dde-84b8-b8f5fedeedf6 61 fields · synced Oct 5, 2026