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Top Touch Nitrile Ultrasoft
EUDAMEDClass I (EU MDR)
Ref GLOBN32-AKZ-IB-XS1Ref GLOBN30-AKZ-MC-XS1
Identity
- Trade Name
- TOP TOUCH NITRILE ULTRASOFT EUDAMED
- Device Name
- GLOVES EUDAMED
- Model / Reference
- GLOBN32-AKZ-IB-XS1 EUDAMEDGLOBN30-AKZ-MC-XS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476642730 EUDAMED04250476639761 EUDAMED
- Basic UDI-DI
- 42504766GLOUP EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDSweden 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
Top Touch Nitrile Ultrasoft by Akzenta International SA — 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 | 42504766GLOUP | Class I | Active |
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Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (2)
- EUDAMED 04d709e2-acec-49c9-8302-fe1d9f5afcd0 61 fields · synced Jul 17, 2026
- EUDAMED 647b0c65-423c-4cfd-bdea-152aee269095 61 fields · synced May 17, 2026