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Surgical drape
EUDAMEDClass I (EU MDR)
Ref 45-75Model 10×20cm,20×30cm,30×30cm,37×45cm,50×50cm,50×75cm,60×60cm,70×70cm,75×90cm,80×80cm,90×90cm,100×100cm,100×150cm,100×300cm,110×110cm,120×120cm,150×150cm,150×200cm,150×240cm,150×250cm,160×160cm,200×200cm,200×300cm,customized
Identity
- Device Name
- Surgical drape EUDAMED
- Model / Reference
- 10×20cm,20×30cm,30×30cm,37×45cm,50×50cm,50×75cm,60×60cm,70×70cm,75×90cm,80×80cm,90×90cm,100×100cm,100×150cm,100×300cm,110×110cm,120×120cm,150×150cm,150×200cm,150×240cm,150×250cm,160×160cm,200×200cm,200×300cm,customized EUDAMED45-75 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976594011460 EUDAMED
- Basic UDI-DI
- 697659401SD002KW EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Surgical drape by Anhui Promise Healthcare 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 | 697659401SD002KW | Class I | Active |
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Manufacturer
- Manufacturer
- Anhui Promise Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000039766
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3ca165b3-1842-4a61-a7b0-c24abc5e61ed 61 fields · synced Jun 18, 2026