Identity
- Device Name
- Sterile Latex Surgical Gloves EUDAMED
- Model / Reference
- 3984 EUDAMED3992 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949153920114 EUDAMED
- Basic UDI-DI
- B-06949153920114 EUDAMED69491539GLOVES04K3 EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMEDT010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class IIa 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 Surgical Gloves by Shandong Yuyuan Latex Gloves Co., LTD. — Class IIa — 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 | B-06949153920114 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-06949153920114 | Class IIa | 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 (2)
- EUDAMED 55977efc-7df3-4178-9cf8-2a4772270017 61 fields · synced Jul 8, 2026
- EUDAMED 73b31d7c-184f-4f61-849e-41082d1fb1ce 61 fields · synced May 16, 2026