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One system colostomy bag

EUDAMED

Class I (EU MDR)

Ref 101085Ref 101170Ref 101070

by Wuhan Sitaili Medical Apparatus Development Co., Ltd

Identity

Trade Name
One system colostomy bag EUDAMED
Device Name
One system colostomy bag EUDAMED
Colostomy Bag EUDAMED
Model / Reference
101085 EUDAMED
101170 EUDAMED
101070 EUDAMED

Identifiers

Primary DI / UDI-DI
16937359411823 EUDAMED
16937359411847 EUDAMED
16937359411816 EUDAMED
Basic UDI-DI
69373594101085ZV EUDAMED
69373594101170ZM EUDAMED
69373594101070ZG EUDAMED
Direct Marketing DI
16937359411823 EUDAMED
16937359411847 EUDAMED
16937359411816 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
Romania 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

One system colostomy bag by Wuhan Sitaili Medical Apparatus Development 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
Wuhan Sitaili Medical Apparatus Development Co., Ltd
EUDAMED SRN
CN-MF-000010103
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (3)

  • EUDAMED f06a8b13-61a7-4577-a73a-092071bfab8d 61 fields · synced Sep 18, 2026
  • EUDAMED 341c55e8-e9cc-4fb8-a178-6b163d5e387a 61 fields · synced May 17, 2026
  • EUDAMED 7824f574-41e3-4021-af03-9c85b671d32e 61 fields · synced May 18, 2026