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Sterile Surgical Gown
EUDAMEDClass I (EU MDR)
Ref H03004Model Standard PerformanceRef Standard, LModel Standard
Identity
- Device Name
- Sterile Surgical Gown EUDAMEDSurgical gown EUDAMED
- Model / Reference
- Standard Performance EUDAMEDH03004 EUDAMEDStandard EUDAMEDStandard, L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973141150467 EUDAMED
- Basic UDI-DI
- 697314115N90000YJ EUDAMED
- EMDN Code
- T020401 STANDARD 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697314115N90000YJ | Class I | Active |
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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 (3)
- EUDAMED daf7d1a1-0637-4821-a97d-ebbd692436df 61 fields · synced Oct 6, 2026
- EUDAMED edf959f9-eb8b-4136-b1fa-4f16b3702abe-1 61 fields · synced Oct 6, 2026
- EUDAMED edf959f9-eb8b-4136-b1fa-4f16b3702abe-2 61 fields · synced Oct 6, 2026