Identity
- Trade Name
- Steri-Soaker Blue EUDAMED
- Device Name
- Steri-Soaker Blue EUDAMED
- Model / Reference
- 50Z805B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840161304186 EUDAMED
- Basic UDI-DI
- B-00840161304186 EUDAMED
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Instrument tray, reusable
Steri-Soaker Blue by Zirc Dental Products, Inc. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840161304186 | Class I | Active |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (1)
- EUDAMED 2408dd92-bc27-4918-8534-3defc74636bc 61 fields · synced Jul 21, 2026