Identity
- Trade Name
- ANNE One System EUDAMED
- Device Name
- ANNE One System EUDAMED
- Model / Reference
- SA-004-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860004541738 EUDAMED
- Basic UDI-DI
- 08500642100JG EUDAMED
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
Classification
- Device Class
- Class IIb 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
ANNE One System by Sibel Health Inc. — Class IIb — 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 | 08500642100JG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sibel Health Inc.
- EUDAMED SRN
- US-MF-000037280
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 6fcc4cc3-9f51-40cc-a923-28c26f9a5244 61 fields · synced Jun 20, 2026