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Surgical drape

EUDAMED

Class I (EU MDR)

Ref L12104BModel 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

by Anhui Promise Healthcare Co., Ltd.

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 EUDAMED
L12104B EUDAMED

Identifiers

Primary DI / UDI-DI
06976594010852 EUDAMED
Basic UDI-DI
697659401SD001KU EUDAMED
EMDN Code
T02010101 INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT 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

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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 5319b9b5-fa08-4d4c-8854-b9e1e1361b9e 61 fields · synced Jun 18, 2026