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One-Piece Urostomy Bag

EUDAMED

Class I (EU MDR)

Ref 5585Model 63226,63228,63307,63309,53201,53202,63315,63316,13203,13303,5985K,5985L,5985G,14103,15202E,15202H,14222,14222G,16810A,16810G,5585,5585G,61003,63005,63006,63013,63014,63103,63104,53001,53003,63105,63106,13003,13103,10451,13005

by Concarey Medical Technology Co., Ltd

Identity

Trade Name
One-Piece Urostomy Bag EUDAMED
Device Name
One-Piece Ostomy Bag EUDAMED
Model / Reference
63226,63228,63307,63309,53201,53202,63315,63316,13203,13303,5985K,5985L,5985G,14103,15202E,15202H,14222,14222G,16810A,16810G,5585,5585G,61003,63005,63006,63013,63014,63103,63104,53001,53003,63105,63106,13003,13103,10451,13005 EUDAMED
5585 EUDAMED

Identifiers

Primary DI / UDI-DI
06975700085777 EUDAMED
Basic UDI-DI
6975700081POstomyBagCX EUDAMED
EMDN Code
A1001030101 ONE-PIECE UROSTOMY BAGS FOR NON-RETRACTED STOMA, FLAT, W/O TISSUE COVER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Slovenia 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-Piece Urostomy Bag by Concarey Medical Technology 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
Concarey Medical Technology Co., Ltd
EUDAMED SRN
CN-MF-000035609
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (1)

  • EUDAMED c02cf768-d07a-48cd-b6f9-365848ebfc39 61 fields · synced Jun 18, 2026