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Huayuan
EUDAMEDFDA UDIClass I (EU MDR)
Ref nitrile,blue,LRef nitrile,blue,SRef nitrile,blue,XXLRef nitrile,black,SRef nitrile,,black,MRef nitrile,,black,XLRef nitrile,,black,L
Identity
- Trade Name
- HUAYUAN EUDAMEDFDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile Examination Gloves EUDAMEDNitrile examination gloves,blue,S FDA UDINitrile examination gloves,blue,L FDA UDINitrile examination gloves,blue,XXL FDA UDI
- Model / Reference
- nitrile,blue,L EUDAMEDnitrile,blue,S EUDAMEDnitrile,blue,XXL EUDAMEDnitrile,black,S EUDAMEDnitrile,,black,M EUDAMEDnitrile,,black,XL EUDAMEDnitrile,,black,L EUDAMEDNitrile FDA UDI
- Description
- Nitrile examination gloves,blue,S FDA UDINitrile examination gloves,blue,L FDA UDINitrile examination gloves,blue,XXL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973082130122 EUDAMEDFDA UDI06973082130108 EUDAMEDFDA UDI06973082130146 EUDAMEDFDA UDI06973082130726 EUDAMED06973082130733 EUDAMED06973082130757 EUDAMED06973082130740 EUDAMED
- Basic UDI-DI
- 697308213NBR-HY-01AA EUDAMED
- 510(k) Number
- K131823 FDA UDI
- FDA Product Code
- LZA FDA UDI
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMEDT01010202 NITRILE SURGICAL GLOVES EUDAMED
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Market of Registration
- Finland EUDAMEDIreland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDINot in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Huayuan by Dongtai City Huayi Gloves Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697308213NBR-HY-01AA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (17)
- EUDAMED 18ea02f4-7f45-452d-b07e-10d396a548d6 61 fields · synced Sep 17, 2026
- EUDAMED 53274231-7af9-407a-b2c2-4cbae4ed1218 61 fields · synced May 17, 2026
- EUDAMED 42f8b1a6-a80e-44d8-b311-af4d4b7cb6e4 61 fields · synced May 17, 2026
- EUDAMED b1f98c38-2311-49aa-bb72-18c4b1722f85 61 fields · synced May 17, 2026
- EUDAMED c82a9a5a-6ef4-418f-8bdc-f390d445ea99 61 fields · synced May 18, 2026
- EUDAMED ecc8d548-321c-43a6-a829-1ff670bf92db 61 fields · synced May 19, 2026
- EUDAMED f949e47c-01e6-40c0-af4a-6f61ecdd58cb 61 fields · synced May 19, 2026
- FDA UDI 5c6fc6c1-7b64-40e4-a250-a975fcfcd0b6 35 fields · synced May 27, 2026
- FDA UDI 0eacb28d-abcc-4d67-ad5f-abd61a4dfee6 35 fields · synced May 30, 2026
- FDA UDI 4dc18f45-464b-4e99-8ff7-acf3dddb0752 35 fields · synced May 30, 2026
- EUDAMED 53274231-7af9-407a-b2c2-4cbae4ed1218-1 61 fields · synced Jun 20, 2026
- EUDAMED 18ea02f4-7f45-452d-b07e-10d396a548d6-1 61 fields · synced Jul 9, 2026
- EUDAMED ecc8d548-321c-43a6-a829-1ff670bf92db-1 61 fields · synced Jul 10, 2026
- EUDAMED c82a9a5a-6ef4-418f-8bdc-f390d445ea99-1 61 fields · synced Jul 12, 2026
- EUDAMED 42f8b1a6-a80e-44d8-b311-af4d4b7cb6e4-1 61 fields · synced Jul 20, 2026
- EUDAMED f949e47c-01e6-40c0-af4a-6f61ecdd58cb-1 61 fields · synced Jul 25, 2026
- EUDAMED b1f98c38-2311-49aa-bb72-18c4b1722f85-1 61 fields · synced Sep 17, 2026