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Ostomy bags and attachments

EUDAMED

Class I (EU MDR)

Ref one-piece opening ostomy bag 7001Model one-piece opening ostomy bag One-piece closing ostomy bag one-piece urinary ostomy bag two-piece opening ostomy bag two-piece closing ostomy bag two-piece urinary ostomy bag two-piece chassis Ostomy care etc

by Saibainian Medical Technology (Wuhan) Co., Ltd.

Identity

Device Name
Ostomy bags and attachments EUDAMED
Model / Reference
one-piece opening ostomy bag One-piece closing ostomy bag one-piece urinary ostomy bag two-piece opening ostomy bag two-piece closing ostomy bag two-piece urinary ostomy bag two-piece chassis Ostomy care etc EUDAMED
one-piece opening ostomy bag 7001 EUDAMED

Identifiers

Primary DI / UDI-DI
06974058870011 EUDAMED
Basic UDI-DI
697405887OB01MR EUDAMED
EMDN Code
A1001010101 ONE-PIECE COLOSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

Ostomy bags and attachments by Saibainian Medical Technology (wuhan) 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
Saibainian Medical Technology (Wuhan) Co., Ltd.
EUDAMED SRN
CN-MF-000038869
Authorised Representative
Sungo Cert GmbH DE-AR-000010869

Sources (1)

  • EUDAMED 59c54cd2-1439-462e-9122-bfac1ca1445f 61 fields · synced Oct 6, 2026