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Disposable urinary drainage bag

EUDAMED

Class I (EU MDR)

Ref CU-FPB-TT-1500mlModel CU-FPA-TT-2000ml

by Changzhou CareU Medical Instruments Co., Ltd.

Identity

Trade Name
Disposable urinary drainage bag EUDAMED
Device Name
Disposable urinary drainage bag EUDAMED
Model / Reference
CU-FPA-TT-2000ml EUDAMED
CU-FPB-TT-1500ml EUDAMED

Identifiers

Primary DI / UDI-DI
06972992510512 EUDAMED
Basic UDI-DI
697299251NOSTVF EUDAMED
EMDN Code
A06030301 URINE COLLECTION BAGS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Spain 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

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Disposable urinary drainage bag by Changzhou CareU Medical Instruments 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

EUDAMED SRN
CN-MF-000027623
Authorised Representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Sources (1)

  • EUDAMED 6e71ed32-1081-44f0-a2a2-ae2e836b170d 61 fields · synced Jun 19, 2026