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MANI - Steri-Endo Guard - Endo Holder - Hand - White - 1 Count
EUDAMEDClass I (EU MDR)
Ref 50Z450A-MANI
Identity
- Trade Name
- MANI - Steri-Endo Guard - Endo Holder - Hand - White - 1 Count EUDAMED
- Device Name
- Dental Cleaning, Sterilization, Disinfection Accessories EUDAMED
- Model / Reference
- 50Z450A-MANI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840161311566 EUDAMED
- Basic UDI-DI
- 0840161300083F 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
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: Instrument tray, reusable
MANI - Steri-Endo Guard - Endo Holder - Hand - White - 1 Count by Zirc Dental Products, 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 | 0840161300083F | 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 7ae72d0e-7c11-413f-ae72-1defe914245a 61 fields · synced Oct 5, 2026