Identity
- Trade Name
- Zense Latex Powdered Examination Gloves EUDAMED
- Device Name
- Latex Powdered Examination Gloves EUDAMED
- Model / Reference
- 3709 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555123602354 EUDAMED
- Basic UDI-DI
- 955512360CISBPPLP5 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
Zense Latex Powdered 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 | 955512360CISBPPLP5 | 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 38eb03be-3745-43b1-befb-46fddce4ae50 61 fields · synced Jun 17, 2026