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Aamedix Latex Sterile Powdered Surgical Gloves, Thermoform Bi-Fold
EUDAMEDClass IIa (EU MDR)
Ref AA 11580-L-SUR-PModel LATEX STERILE POWDERED SURGICAL GLOVES
Identity
- Trade Name
- AAMEDIX LATEX STERILE POWDERED SURGICAL GLOVES, THERMOFORM BI-FOLD EUDAMED
- Device Name
- LATEX STERILE POWDERED SURGICAL GLOVES EUDAMED
- Model / Reference
- LATEX STERILE POWDERED SURGICAL GLOVES EUDAMEDAA 11580-L-SUR-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 19551015255803 EUDAMED
- Basic UDI-DI
- 95510152547179QV EUDAMED
- EMDN Code
- T01010101 POWDERED LATEX SURGICAL 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
Aamedix Latex Sterile Powdered Surgical Gloves, Thermoform Bi-Fold by Aamedix Glove Sdn Bhd — Class IIa — 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 | 95510152547179QV | Class IIa | 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 03f33822-f158-40c7-8637-3fd0b0a5f6e5 61 fields · synced Oct 6, 2026