Identity
- Trade Name
- AcuTop EUDAMED
- Device Name
- AcuTop Gitter Tape_XXL_Beige EUDAMED
- Model / Reference
- AcuTop Gitter Tape EUDAMEDXXL_Beige EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809931360809 EUDAMED
- Basic UDI-DI
- 880102212DDGCU EUDAMED
- EMDN Code
- H900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
AcuTop by Atex Co., Ltd — 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 | 880102212DDGCU | Class I | Active |
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Manufacturer
- Manufacturer
- Atex Co., Ltd
- EUDAMED SRN
- KR-MF-000012358
- Authorised Representative
- Javitech Consulting GmbH DE-AR-000045915
Sources (1)
- EUDAMED 6e08d039-f67a-4892-ba4a-389b0a5d1ce5 61 fields · synced Oct 6, 2026