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Alèses plastifiées

EUDAMED

Class I (EU MDR)

Ref 4094Model 43x38cm, 45x45cm, 50x45cm, 50x50cm, 60x50cm, 60x60cm, 75x45cm, 75x75cm, 75x90cm, 90x85cm, 90x90cm, 70x200cm, 75x140cm, 75x175cm, 75x210cm, 78x140cm, 78x175cm, 78x210cm, 80x150cm, 80x175cm, 80x210cm, 100x200cm

by Changzhou Newrise Medical & Hygiene Products Co., Ltd

Identity

Trade Name
Alèses plastifiées EUDAMED
Device Name
Protective sheet EUDAMED
Model / Reference
43x38cm, 45x45cm, 50x45cm, 50x50cm, 60x50cm, 60x60cm, 75x45cm, 75x75cm, 75x90cm, 90x85cm, 90x90cm, 70x200cm, 75x140cm, 75x175cm, 75x210cm, 78x140cm, 78x175cm, 78x210cm, 80x150cm, 80x175cm, 80x210cm, 100x200cm EUDAMED
4094 EUDAMED

Identifiers

Primary DI / UDI-DI
06976325666020 EUDAMED
Basic UDI-DI
697632566PROTSHTH5 EUDAMED
Direct Marketing DI
06976325666020 EUDAMED
EMDN Code
T04010299 ABSORBENT UNDERPADS - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
France 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

Alèses plastifiées by Changzhou Newrise Medical & Hygiene Products Co., Ltd — Class I — CE/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-000013196
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED f904b6bc-30e0-4772-bfa8-70ffda043bb2 61 fields · synced Oct 7, 2026