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Extremity Drape
EUDAMEDClass I (EU MDR)
Ref RFEO03-6010-2L-SRef RFEO03-6012-2L-S
Identity
- Trade Name
- Extremity Drape EUDAMED
- Device Name
- Extremity Drape EUDAMED
- Model / Reference
- RFEO03-6010-2L-S EUDAMEDRFEO03-6012-2L-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975085701118 EUDAMED06975085701101 EUDAMED
- Basic UDI-DI
- 697508570SD05MG EUDAMED
- EMDN Code
- T02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
Extremity 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 | 697508570SD05MG | 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 (2)
- EUDAMED 60c9af76-d45a-48ed-a1ab-323e4afe4389 61 fields · synced Oct 6, 2026
- EUDAMED cecd54ea-34d6-4376-be82-b7612112851e 61 fields · synced May 18, 2026