Identity
- Trade Name
- Cyntek Latex Powder Free Examination Gloves EUDAMED
- Device Name
- Latex Powdered Free Examination Gloves EUDAMED
- Model / Reference
- 7839 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555123602149 EUDAMED
- Basic UDI-DI
- 955512360CISBPFLN7 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
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
Cyntek Latex Powder Free Examination Gloves by Cranberry International Sdn. Bhd. — 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 | 955512360CISBPFLN7 | Class I | Active |
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Manufacturer
- Manufacturer
- Cranberry International Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000004878
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 655d8ca3-a339-427c-b064-b4fba0c19ae4 61 fields · synced Jun 18, 2026