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Anne Chest Adhesive, Standard Wear
EUDAMEDClass IIb (EU MDR)
Ref 900-00037Model SA-004-01
Identity
- Trade Name
- Anne Chest Adhesive, Standard Wear EUDAMED
- Device Name
- ANNE One System EUDAMED
- Model / Reference
- SA-004-01 EUDAMED900-00037 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850064210170 EUDAMED
- Basic UDI-DI
- 08500642100JG EUDAMED
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES 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
Category: General-purpose multi-parameter bedside monitor
Anne Chest Adhesive, Standard Wear by Sibel Health Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 dbfda22e-b3af-45dc-849c-d5786db13050 61 fields · synced Jun 18, 2026