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Surgical Gown

EUDAMED

Class I (EU MDR)

Ref Reinforced, XLModel Reinforced

by Hubei Haixin Protective Products Group Co., Ltd.

Identity

Device Name
Surgical Gown EUDAMED
Model / Reference
Reinforced EUDAMED
Reinforced, XL EUDAMED

Identifiers

Primary DI / UDI-DI
16973141150549 EUDAMED
Basic UDI-DI
697314115N90001YL EUDAMED
EMDN Code
T020402 REINFORCED SURGICAL GOWNS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Surgical Gown 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 (2)

  • EUDAMED 0e60bfd3-a942-4807-99d8-34b83c88f1f0-1 61 fields · synced Jun 19, 2026
  • EUDAMED 0e60bfd3-a942-4807-99d8-34b83c88f1f0-2 61 fields · synced Jun 19, 2026