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Sterile Surgical Gown

EUDAMED

Class I (EU MDR)

Ref H03007Model Standard PerformanceRef H03010Model High PerformanceRef H03002Ref H03008Ref H03012Ref H03009Ref H03006Ref H03014Ref H03005Ref Standard, XXXLModel StandardRef Standard, XLRef Reinforced, SModel ReinforcedRef Reinforced, MRef Reinforced, XLRef Reinforced, XSRef Reinforced, LRef Reinforced, XXXLRef Standard, XSRef Standard, SRef Standard, XXLRef S

by Hubei Haixin Protective Products Group Co., Ltd.

Identity

Trade Name
Sterile Surgical Gown EUDAMED
Device Name
Sterile Surgical Gown EUDAMED
Surgical gown EUDAMED
Model / Reference
Standard Performance EUDAMED
H03007 EUDAMED
High Performance EUDAMED
H03010 EUDAMED
H03002 EUDAMED
H03008 EUDAMED
H03012 EUDAMED
H03009 EUDAMED
H03006 EUDAMED
H03014 EUDAMED
H03005 EUDAMED
Standard EUDAMED
Standard, XXXL EUDAMED
Standard, XL EUDAMED
Reinforced EUDAMED
Reinforced, S EUDAMED
Reinforced, M EUDAMED
Reinforced, XL EUDAMED
Reinforced, XS EUDAMED
Reinforced, L EUDAMED
Reinforced, XXXL EUDAMED
Standard, XS EUDAMED
Standard, S EUDAMED
Standard, XXL EUDAMED
S EUDAMED

Identifiers

Primary DI / UDI-DI
06973141150498 EUDAMED
06973141150528 EUDAMED
06973141150443 EUDAMED
06973141150504 EUDAMED
06973141150542 EUDAMED
06973141150511 EUDAMED
06973141150481 EUDAMED
06973141150566 EUDAMED
06973141150474 EUDAMED
16973141150471 EUDAMED
16973141150532 EUDAMED
16973141150495 EUDAMED
16973141150501 EUDAMED
16973141150433 EUDAMED
16973141150464 EUDAMED
Basic UDI-DI
697314115N90000YJ EUDAMED
697314115N90001YL EUDAMED
EMDN Code
T020401 STANDARD SURGICAL GOWNS EUDAMED
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

Sterile 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

Manufacturer
Hubei Haixin Protective Products Group Co., Ltd.
EUDAMED SRN
CN-MF-000026316
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (29)

  • EUDAMED 6ee12b50-f98c-4bb2-8334-ff86e9bce5b9 61 fields · synced Oct 6, 2026
  • EUDAMED 80f090e1-d07e-43ce-81b9-0071de9d03ac 61 fields · synced May 17, 2026
  • EUDAMED 097fb87b-edde-4d20-8e7b-1cf6025ec1a2 61 fields · synced May 17, 2026
  • EUDAMED 8f984a5b-d2ce-433d-b7f7-ca5ec9b41354 61 fields · synced May 17, 2026
  • EUDAMED e82f64f4-90bd-4d26-8756-e87f63eb64cf 61 fields · synced May 18, 2026
  • EUDAMED 58daa856-68f0-409a-a58a-210c4f534654 61 fields · synced May 18, 2026
  • EUDAMED ef2d9aa7-445e-4db7-9a17-42f8759b3564 61 fields · synced May 18, 2026
  • EUDAMED 5ef36bd6-06fe-425e-a90d-f6c50aa97d51 61 fields · synced May 18, 2026
  • EUDAMED deaffd75-daa3-410e-9b59-795a639f90d2 61 fields · synced May 19, 2026
  • EUDAMED 8d8bb5f3-dcd0-4926-bf33-82168cf4d845-1 61 fields · synced Jul 9, 2026
  • EUDAMED 8d8bb5f3-dcd0-4926-bf33-82168cf4d845-2 61 fields · synced Jul 9, 2026
  • EUDAMED f8c951d9-6272-4204-9d17-9e9e007e35ba-1 61 fields · synced Jul 9, 2026
  • EUDAMED 4b7e900c-13ba-4093-8501-abd1c4ec8171-1 61 fields · synced Jul 9, 2026
  • EUDAMED 17409a59-b4d5-4236-955a-d35188ecc7e4-1 61 fields · synced Jul 9, 2026
  • EUDAMED 0cb4e4eb-8069-4ba3-b2d9-2a1c703f54ed-1 61 fields · synced Jul 9, 2026
  • EUDAMED 771c22c4-7f5f-423d-a313-05290b3b065f-1 61 fields · synced Jul 11, 2026
  • EUDAMED 667b9733-44bf-4792-adbe-e80550e7d36e-1 61 fields · synced Jul 13, 2026
  • EUDAMED 667b9733-44bf-4792-adbe-e80550e7d36e-2 61 fields · synced Jul 13, 2026
  • EUDAMED 93e011f6-ca33-4e21-b7d7-bc477ff2f059-1 61 fields · synced Jul 13, 2026
  • EUDAMED 93e011f6-ca33-4e21-b7d7-bc477ff2f059-2 61 fields · synced Jul 13, 2026
  • EUDAMED 66fe7853-f8ca-4f9a-acbb-6d6a7c364c96-1 61 fields · synced Jul 14, 2026
  • EUDAMED 764599d7-3a9f-4c34-a568-3ccf4ca225a6-1 61 fields · synced Jul 14, 2026
  • EUDAMED 205f071a-8049-49c7-bdd4-ca966741ae67-1 61 fields · synced Jul 16, 2026
  • EUDAMED 205f071a-8049-49c7-bdd4-ca966741ae67-2 61 fields · synced Jul 16, 2026
  • EUDAMED d6edc462-0b5f-4bb9-845b-bfe1ef6f08f1-1 61 fields · synced Jul 17, 2026
  • EUDAMED d6edc462-0b5f-4bb9-845b-bfe1ef6f08f1-2 61 fields · synced Jul 17, 2026
  • EUDAMED 480903bf-ba81-479f-9541-0878166fdefa-1 61 fields · synced Jul 21, 2026
  • EUDAMED b13f47f4-d1b1-4e56-8233-967b863c04cf-1 61 fields · synced Jul 29, 2026
  • EUDAMED 3d825a17-4e9e-4aae-9b23-5236ea704151 61 fields · synced Aug 2, 2026