Identity
- Trade Name
- Active+me REMOTE EUDAMED
- Device Name
- Active+me REMOTE App EUDAMED
- Model / Reference
- P102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060293171004 EUDAMED
- Basic UDI-DI
- 5060293171004SV EUDAMED
- EMDN Code
- V92 MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Northern Ireland 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
Active+me REMOTE by Aseptika Limited — 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 | 5060293171004SV | Class I | Active |
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Manufacturer
- Manufacturer
- Aseptika Limited
- EUDAMED SRN
- UK-MF-000037607
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED b5ba3adf-9ebf-400c-bd75-cd2739ea36b8 61 fields · synced Jul 8, 2026