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Latex Examination / Treatment Gloves
EUDAMEDClass I (EU MDR)
Ref 5345Model XS，S,M,L,XL
Identity
- Device Name
- LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
- Model / Reference
- XS，S,M,L,XL EUDAMED5345 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949153953457 EUDAMED
- Basic UDI-DI
- 69491539GLOVES06K7 EUDAMED
- Unit of Use DI
- 06949153953440 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
Latex Examination / Treatment Gloves by Shandong Yuyuan Latex 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 | 69491539GLOVES06K7 | Class I | Active |
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Manufacturer
- Manufacturer
- Shandong Yuyuan Latex Gloves Co., LTD.
- EUDAMED SRN
- CN-MF-000033447
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED f38fdc98-91ef-4322-a0a4-4a97382b2d7e 61 fields · synced Jul 26, 2026