← Back to catalogue

Ostomy Pouch

EUDAMED

Class I (EU MDR)

Ref 10Model EB300101Model BB300101Model EM164001Model EM224002

by Shenzhen Pump Medical System Co., Ltd

Identity

Trade Name
Ostomy Pouch EUDAMED
Device Name
Ostomy Pouch EUDAMED
Model / Reference
EB300101 EUDAMED
10 EUDAMED
BB300101 EUDAMED
EM164001 EUDAMED
EM224002 EUDAMED

Identifiers

Primary DI / UDI-DI
06947679702320 EUDAMED
06947679702351 EUDAMED
06947679702214 EUDAMED
06947679702207 EUDAMED
Basic UDI-DI
6947679702320GL EUDAMED
6947679702351GX EUDAMED
6947679702214GL EUDAMED
6947679702207GP EUDAMED
EMDN Code
T0499 INCONTINENCE DEVICES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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 Pouch by Shenzhen Pump Medical System 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shenzhen Pump Medical System Co., Ltd
EUDAMED SRN
CN-MF-000031216
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED d184ba17-b186-4684-b7c4-3395cbf4f44b 61 fields · synced Jul 23, 2026
  • EUDAMED 23bf03f2-027b-42d5-bd1a-91ecde20633a 61 fields · synced May 17, 2026
  • EUDAMED ba37680e-f6f1-4f26-944d-018affc8e772 61 fields · synced May 19, 2026
  • EUDAMED 3ef830ed-3344-4769-b555-dd47f47f8258 61 fields · synced May 19, 2026