Identity
- Trade Name
- SCLH2O23-5 EUDAMED
- Device Name
- 50SCS01B EUDAMED
- Model / Reference
- 50SCS01B EUDAMEDSCLH2O23-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00653159012464 EUDAMED
- Basic UDI-DI
- 0653159SC0006TESCW EUDAMED
- Direct Marketing DI
- 00653159012464 EUDAMED
- EMDN Code
- S9080 DEVICES FOR STERILISATION (EXCLUDING CAT. D - Z) - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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: Sterilizer/disinfector rack
Sclh2o23-5 by Case Medical Inc — Class I — 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 | 0653159SC0006TESCW | Class I | Active |
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Manufacturer
- Manufacturer
- Case Medical Inc
- EUDAMED SRN
- US-MF-000036357
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 50d76182-bf70-4a47-9e9a-6f6e72137ad5 61 fields · synced Sep 30, 2026