Identity
- Trade Name
- VIVO Pen EUDAMEDVIVO EUDAMED
- Device Name
- VIVO Pen EUDAMEDVIVO EUDAMED
- Model / Reference
- 200 EUDAMED100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 9120112972000 EUDAMED09120112971102 EUDAMED
- Basic UDI-DI
- 9120112972006E EUDAMED91201129710069 EUDAMED
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES EUDAMEDZ12101106 NEUROLOGICAL STIMULATORS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
VIVO Pen by AURIMOD GmbH — 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 | 9120112972006E | Class I | Active |
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Manufacturer
- Manufacturer
- AURIMOD GmbH
- EUDAMED SRN
- AT-MF-000000433
Sources (2)
- EUDAMED 792c86f0-37fb-44ba-b8a1-e9ee63b98b97 61 fields · synced Jul 24, 2026
- EUDAMED bc114378-5c8c-425d-9188-fe3f322ee017 61 fields · synced May 18, 2026