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Style Edition
EUDAMEDClass I (EU MDR)
Ref GLOBL33-AKZ-FU-M01Ref GLOBL33-AKZ-MB-M01Ref GLOBL33-AKZ-MB-XS1Ref GLOBL33-AKZ-FG-LL1Ref GLOBN30-AKZ-PH-XS1Ref GLOBL33-AKZ-PI-M01
Identity
- Trade Name
- STYLE EDITION EUDAMED
- Device Name
- GLOVES EUDAMED
- Model / Reference
- GLOBL33-AKZ-FU-M01 EUDAMEDGLOBL33-AKZ-MB-M01 EUDAMEDGLOBL33-AKZ-MB-XS1 EUDAMEDGLOBL33-AKZ-FG-LL1 EUDAMEDGLOBN30-AKZ-PH-XS1 EUDAMEDGLOBL33-AKZ-PI-M01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476641085 EUDAMED04250476643447 EUDAMED04250476643423 EUDAMED04250476643188 EUDAMED04250476643355 EUDAMED04250476643478 EUDAMED
- Basic UDI-DI
- 42504766GLOUP EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMEDT01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMEDHungary EUDAMEDGermany EUDAMEDSweden EUDAMEDCzechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Style Edition 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 (6)
- EUDAMED eedd1c67-c1db-4712-808c-267aced1f73a 61 fields · synced Oct 6, 2026
- EUDAMED e0e164e7-9885-4fd6-92b1-009ad123e3e9 61 fields · synced May 16, 2026
- EUDAMED eb2f475d-40ea-4542-a4c5-4558e16784cd 61 fields · synced May 17, 2026
- EUDAMED 2a8625a8-4201-4d29-8ed1-ceab590398f4 61 fields · synced May 18, 2026
- EUDAMED bba450d9-57bd-413a-a50f-b0e713ab2ea6 61 fields · synced May 18, 2026
- EUDAMED 70a394a4-04c4-4bfb-84b0-ac43c974f4fb 61 fields · synced May 19, 2026