Identity
- Device Name
- Sterile Latex Examination Gloves EUDAMED
- Model / Reference
- 3992 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949153951279 EUDAMED
- Basic UDI-DI
- 69491539GLOVES02JX EUDAMEDB-06949153951279 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Sterile Latex Examination Gloves by Shandong Yuyuan Latex Gloves Co., LTD. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69491539GLOVES02JX | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69491539GLOVES02JX | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shandong Yuyuan Latex Gloves Co., LTD.
- EUDAMED SRN
- CN-MF-000033447
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (2)
- EUDAMED d9668514-f906-45ea-82fb-5e742a8100f0 61 fields · synced Jun 19, 2026
- EUDAMED 22c77187-6b87-4a1f-b904-8fe9e8e0a034 61 fields · synced May 19, 2026