Identity
- Trade Name
- huayuan EUDAMED
- Device Name
- Nitrile Examination Gloves EUDAMED
- Model / Reference
- nitrile,,black,XXL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973082130801 EUDAMED
- Basic UDI-DI
- 697308213NBR-HY-01AA EUDAMED
- EMDN Code
- T01010202 NITRILE SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
huayuan by Dongtai City Huayi Gloves 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 | 697308213NBR-HY-01AA | Class I | Active |
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Manufacturer
- Manufacturer
- Dongtai City Huayi Gloves Co., Ltd.
- EUDAMED SRN
- CN-MF-000019047
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 5b782bb2-444c-401a-8829-7b28e2905d49 61 fields · synced May 22, 2026