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Crystal HD® - Resin Mouth Mirror - #4 Soft Grip Double-Sided - 1 Count Sample P…
EUDAMEDClass I (EU MDR)
Ref 50Z384SMPLRef 50Z384PRef 50Z384SMPL-INTLRef 50Z384QRef 50Z384SRef 50Z384N
Identity
- Trade Name
- Crystal HD® - Resin Mouth Mirror - #4 Soft Grip Double-Sided - 1 Count Sample Pack EUDAMEDCrystal HD® - Resin Mouth Mirror - #4 Soft Grip Double-Sided - Neon Green - 12 Count EUDAMEDCrystal HD® - Resin Mouth Mirror - #4 Soft Grip Double-Sided - Neon Orange - 12 Count EUDAMEDCrystal HD® - Resin Mouth Mirror - #4 Soft Grip Double-Sided - Neon Pink - 12 Count EUDAMEDCrystal HD® - Resin Mouth Mirror - #4 Soft Grip Double-Sided - Neon Blue - 12 Count EUDAMED
- Device Name
- Crystal HD Mouth Mirrors EUDAMED
- Model / Reference
- 50Z384SMPL EUDAMED50Z384P EUDAMED50Z384SMPL-INTL EUDAMED50Z384Q EUDAMED50Z384S EUDAMED50Z384N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840161311948 EUDAMED00840161311405 EUDAMED00840161311528 EUDAMED00840161311412 EUDAMED00840161311436 EUDAMED00840161311382 EUDAMED
- Basic UDI-DI
- 0840161300012Z EUDAMED
- EMDN Code
- L160201 DENTAL MIRRORS AND HANDLES, REUSABLE 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
Crystal HD® - Resin Mouth Mirror - #4 Soft Grip Double-Sided - 1 Count Sample P… by Zirc Dental Products, Inc. — Class I — MDR — listed in EUDAMED
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 | 0840161300012Z | 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 (6)
- EUDAMED 436957de-62b5-4c05-a732-385c349ded10 61 fields · synced Jul 29, 2026
- EUDAMED bd8d7461-ac4f-452c-9178-fdc6a9b9758a 61 fields · synced May 17, 2026
- EUDAMED 71342923-1a7d-40ae-a04b-8a376bc473c6 61 fields · synced May 18, 2026
- EUDAMED 4311f031-107f-4149-bd99-2cf69f55d301 61 fields · synced May 18, 2026
- EUDAMED 47f56219-3434-4cdb-99a2-f24c4b2fc5c9 61 fields · synced May 18, 2026
- EUDAMED a1969585-b483-4da0-acc5-d5ca7b4e941f 61 fields · synced May 18, 2026