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Mirror Magic® - Anti-Fog Solution Bottle - 10 Count
EUDAMEDFDA UDIClass I (EU MDR)
Ref 50R205
Identity
- Trade Name
- Mirror Magic® - Anti-Fog Solution Bottle - 10 Count EUDAMEDMirror Magic® Anti-Fog Solution 10-pack FDA UDI
- Generic Name
- Dental antifog solution FDA UDI
- Device Name
- Mirror Magic® System EUDAMEDMirror Magic Anti-Fog Solution 10pk FDA UDI
- Model / Reference
- 50R205 EUDAMEDFDA UDI
- Description
- Mirror Magic Anti-Fog Solution 10pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10840161308112 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840161300163E EUDAMED
- FDA Product Code
- EAX FDA UDI
- EMDN Code
- V0799 PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Dental antifog solution FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 92 Millimeter FDA UDIWidth — 64 Millimeter FDA UDIHeight — 41 Millimeter FDA UDI
Mirror Magic® - Anti-Fog Solution Bottle - 10 Count by Zirc Dental Products, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0840161300163E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Zirc Dental Products Inc.
- EUDAMED SRN
- US-MF-000021065
- Authorised Representative
- Medicom GmbH DE-AR-000005612
Sources (2)
- EUDAMED 60d8aefe-ef84-420a-a4d7-5ac79e353f37 61 fields · synced Jul 9, 2026
- FDA UDI 84fa063a-fe5e-4141-933f-f436c2dc47a4 34 fields · synced May 30, 2026