Identity
- Trade Name
- ADAM EUDAMED
- Device Name
- ADAM EUDAMED
- Model / Reference
- SA-020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860004541776 EUDAMED
- Basic UDI-DI
- 08600045417SA-020DX EUDAMED
- Direct Marketing DI
- 00860004541769 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
Category: Device sterilization/disinfection container, reusable
Adam by Sibel Health Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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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 | 08600045417SA-020DX | Class I | Active |
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Manufacturer
- Manufacturer
- Sibel Health Inc.
- EUDAMED SRN
- US-MF-000037280
- Authorised Representative
- Lorit Consultancy GmbH AT-AR-000035932
Sources (1)
- EUDAMED 3ae6e0c8-97b3-406c-b0d2-0e4d155f3442 61 fields · synced Jun 17, 2026