Identity
- Trade Name
- Natural latex Powder free Size 8 EUDAMED
- Device Name
- Latex Surgical Glove EUDAMED
- Model / Reference
- 420285 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978192900184 EUDAMED
- Basic UDI-DI
- 697240342LSG000001SU EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Natural latex Powder free Size 8 by Henan Zhende Medical Products Co., Ltd. — Class IIa — 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 | 697240342LSG000001SU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Henan Zhende Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000009621
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 9f94ab77-3514-4674-9c6d-25cbd5e13c9e 61 fields · synced Jun 19, 2026