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Art|one
EUDAMEDClass I (EU MDR)
Ref GLOBN34-AKZ-MG-LL1Ref GLOBN51-AKZ-BK-XL1Ref GLOBN51-AKZ-MC-M01Ref GLOBN34-AKZ-MG-M01Ref GLOBN51-AKZ-BK-M01Ref GLOBN51-AKZ-MC-LL1Ref GLOBN51-AKZ-BK-S01Ref GLOBN29-AKZ-FU-S01Ref GLOBN34-AKZ-MG-S01Ref GLOBN34-AKZ-LI-S01Ref GLOBN29-AKZ-FU-XS1Ref GLOBN51-AKZ-BK-XS1Ref GLOBN51-AKZ-BK-LL1Ref GLOBN34-AKZ-MG-XS1Ref GLOBN34-AKZ-LI-XS1Ref GLODL53-AKZ-WH-XS1Ref GLOEL53-AKZ-WH-M01Ref GLOEL53-AKZ-WH-S01Ref GLODL29-AKZ-WH-M01Ref GLODL53-AKZ-WH-LL1Ref GLODL53-AKZ-WH-M01Ref GLOEL53-AKZ-WH-LL1
Identity
- Trade Name
- ART|ONE EUDAMED
- Device Name
- GLOVES EUDAMED
- Model / Reference
- GLOBN34-AKZ-MG-LL1 EUDAMEDGLOBN51-AKZ-BK-XL1 EUDAMEDGLOBN51-AKZ-MC-M01 EUDAMEDGLOBN34-AKZ-MG-M01 EUDAMEDGLOBN51-AKZ-BK-M01 EUDAMEDGLOBN51-AKZ-MC-LL1 EUDAMEDGLOBN51-AKZ-BK-S01 EUDAMEDGLOBN29-AKZ-FU-S01 EUDAMEDGLOBN34-AKZ-MG-S01 EUDAMEDGLOBN34-AKZ-LI-S01 EUDAMEDGLOBN29-AKZ-FU-XS1 EUDAMEDGLOBN51-AKZ-BK-XS1 EUDAMEDGLOBN51-AKZ-BK-LL1 EUDAMEDGLOBN34-AKZ-MG-XS1 EUDAMEDGLOBN34-AKZ-LI-XS1 EUDAMEDGLODL53-AKZ-WH-XS1 EUDAMEDGLOEL53-AKZ-WH-M01 EUDAMEDGLOEL53-AKZ-WH-S01 EUDAMEDGLODL29-AKZ-WH-M01 EUDAMEDGLODL53-AKZ-WH-LL1 EUDAMEDGLODL53-AKZ-WH-M01 EUDAMEDGLOEL53-AKZ-WH-LL1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476645526 EUDAMED04250476645267 EUDAMED04250476644451 EUDAMED04250476645540 EUDAMED04250476643577 EUDAMED04250476644437 EUDAMED04250476643560 EUDAMED04250476642266 EUDAMED04250476645564 EUDAMED04250476643973 EUDAMED04250476642259 EUDAMED04250476643553 EUDAMED04250476643584 EUDAMED04250476645588 EUDAMED04250476643959 EUDAMED04250476646356 EUDAMED04250476640774 EUDAMED04250476640798 EUDAMED04250476645908 EUDAMED04250476646332 EUDAMED04250476646318 EUDAMED04250476640750 EUDAMED
- Basic UDI-DI
- 42504766GLOUP EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMEDT010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMEDAustria EUDAMEDDenmark EUDAMEDGermany EUDAMEDItaly EUDAMEDHungary EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
Art|one 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 (22)
- EUDAMED 273c0ccf-56bc-4fe2-aa6a-da2258dde65d 61 fields · synced Oct 6, 2026
- EUDAMED 799d16ce-0b33-416c-9259-789b47096ee6 61 fields · synced May 11, 2026
- EUDAMED cd19c449-1d6b-4099-b5e1-d6e44ff91ad6 61 fields · synced May 11, 2026
- EUDAMED 13092b92-e966-412e-9e98-b5493315f16a 61 fields · synced May 11, 2026
- EUDAMED 112a1d95-4f89-4870-9dfb-762d824b7479 61 fields · synced May 17, 2026
- EUDAMED 4e600f29-a663-40a9-8a09-43af6ad8c1be 61 fields · synced May 17, 2026
- EUDAMED e54d1ef7-930f-4ebe-946b-56c65fa0c9e3 61 fields · synced May 18, 2026
- EUDAMED 0ed54f4c-af93-47cc-ace0-9f17cddcdc80 61 fields · synced May 18, 2026
- EUDAMED 0ac33729-d12e-40fd-8301-2ebf92ecc71a 61 fields · synced May 18, 2026
- EUDAMED 6bed04e0-b8a7-4702-8346-7856e025a1c4 61 fields · synced May 18, 2026
- EUDAMED fd2b6d7f-137e-44cb-9b40-92888cecabb5 61 fields · synced May 18, 2026
- EUDAMED 8dc0bd74-9a66-458a-b940-fc8aa0b6305c 61 fields · synced May 18, 2026
- EUDAMED da612242-9fc9-48de-af88-1ff7d86e600a 61 fields · synced May 18, 2026
- EUDAMED 9c0da7b3-82e6-4286-bdbd-b4c6001faf6b 61 fields · synced May 19, 2026
- EUDAMED 1b33d522-d594-43fd-ace2-7546d7aab6de 61 fields · synced May 19, 2026
- EUDAMED fe96154b-aed5-4bcb-ab8e-ff3e361c91ee 61 fields · synced Jun 20, 2026
- EUDAMED f6f9f7d3-82f5-4e1f-9639-8db26ec37140 61 fields · synced Jul 9, 2026
- EUDAMED aaa8901f-eb9d-443c-b8c0-ecfecc1463f8 61 fields · synced Jul 9, 2026
- EUDAMED b70bf349-ef50-4cef-b749-74832d983fd7 61 fields · synced Jul 11, 2026
- EUDAMED 7664a0e9-da17-47f1-9b35-25df472b43c8 61 fields · synced Jul 13, 2026
- EUDAMED 0b3a1309-635c-4502-ab72-043b11eb175f 61 fields · synced Jul 25, 2026
- EUDAMED ecaf5b98-fb50-41d5-bd74-c3552c410d77 61 fields · synced Aug 1, 2026