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AAMedix
EUDAMEDClass I (EU MDR)
Ref AA 11147-LTX-PModel Latex Powdered Examination Gloves
Identity
- Trade Name
- AAMedix EUDAMED
- Device Name
- AAMedix Latex Powdered Examination Gloves EUDAMED
- Model / Reference
- Latex Powdered Examination Gloves EUDAMEDAA 11147-LTX-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00723860111470 EUDAMED
- Basic UDI-DI
- 9551015251114-PEU EUDAMED
- Direct Marketing DI
- 00723860111470 EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AAMedix by Aamedix Glove 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 | 9551015251114-PEU | Class I | Active |
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Manufacturer
- Manufacturer
- Aamedix Glove Sdn Bhd
- EUDAMED SRN
- MY-MF-000025086
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b1b5ea2c-3566-4a0f-9c72-fcfde5b95811 61 fields · synced Jun 18, 2026