Identity
- Trade Name
- QUALITY Vinyl Exam Gloves EUDAMED
- Device Name
- Disposable Vinyl Exam Gloves EUDAMED
- Model / Reference
- 979641 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970245758810 EUDAMED
- Basic UDI-DI
- 697024575Vinyl85 EUDAMED
- EMDN Code
- T01020201 VINYL EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
QUALITY Vinyl Exam Gloves by Shandong Intco Medical Products Co., Ltd. — Class I — CE/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 | 697024575Vinyl85 | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Intco Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000002100
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 0516e816-5cbb-44c9-8e1a-447693dd0896 61 fields · synced Oct 6, 2026