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AquaSource Nitrile Powder Free Examination Gloves
EUDAMEDClass I (EU MDR)
Ref 3447
Identity
- Trade Name
- AquaSource Nitrile Powder Free Examination Gloves EUDAMED
- Device Name
- Nitrile Powder Free examination Glove EUDAMED
- Model / Reference
- 3447 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555123603023 EUDAMED
- Basic UDI-DI
- 955512360CISBPFNNB EUDAMED
- EMDN Code
- T01020204 NITRILE 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
No
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
AquaSource Nitrile 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 | 955512360CISBPFNNB | 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 e4a8d73a-7503-41d4-b1ca-ef439ae917a2 61 fields · synced Jun 19, 2026