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Sterile Drapes
EUDAMEDClass I (EU MDR)
Ref 35-006Model 76cm×152cm， 45x75cm with a oval fenestrated hole of 7.5x6cm ，90cm×90cm， 90cm×120cm， 60cm×60cm ，120cmX140cm
Identity
- Trade Name
- Sterile Drapes EUDAMED
- Device Name
- Sterile Drapes EUDAMED
- Model / Reference
- 76cm×152cm， 45x75cm with a oval fenestrated hole of 7.5x6cm ，90cm×90cm， 90cm×120cm， 60cm×60cm ，120cmX140cm EUDAMED35-006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013960074 EUDAMED
- Basic UDI-DI
- 697201396MU01SNNNSSD00172 EUDAMED
- Direct Marketing DI
- 06972013960074 EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Sterile Drapes by Multigate Co., Ltd — 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 | 697201396MU01SNNNSSD00172 | Class I | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED 31620ef4-e7c3-4a75-ba7e-ef9e69050618 61 fields · synced Jun 18, 2026
- EUDAMED 94867d36-17ed-468b-a20f-1514b5b245fe 61 fields · synced Jun 18, 2026