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Non-woven Gowns

EUDAMED

Class I (EU MDR)

Ref Back WearingModel One-Piece, Two-Piece, Back Wearing

by Hubei Haixin Protective Products Group Co., Ltd.

Identity

Device Name
Non-woven Gowns EUDAMED
Model / Reference
One-Piece, Two-Piece, Back Wearing EUDAMED
Back Wearing EUDAMED

Identifiers

Primary DI / UDI-DI
06973141151730 EUDAMED
Basic UDI-DI
697314115N00000VF EUDAMED
EMDN Code
T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) 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

Non-woven Gowns by Hubei Haixin Protective Products Group 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-000026316
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 9f27069c-c676-4754-8d9f-32fe2961b625 61 fields · synced Jun 19, 2026