Identity
- Trade Name
- Mini Mat Neon Yellow EUDAMEDMini Mat FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Device Name
- Mini Mat Neon Yellow EUDAMEDDental Cleaning, Sterilization, Disinfection Accessories EUDAMEDInstrument holder intended for 8 dental instruments for sterilization. FDA UDI
- Model / Reference
- 50Z480O EUDAMED20Z480O EUDAMEDO-Neon Yellow FDA UDI
- Description
- Instrument holder intended for 8 dental instruments for sterilization. FDA UDI
Identifiers
- Catalog Number
- 50Z480O FDA UDI
- Primary DI / UDI-DI
- 00840161301246 EUDAMEDD68550Z480O0 FDA UDI
- Basic UDI-DI
- B-00840161301246 EUDAMED0840161300083F EUDAMED
- FDA Product Code
- FSM FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Sterilization packaging, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
Category: Instrument tray, reusable
Mini Mat Neon Yellow by Zirc Dental Products, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00840161301246 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00840161301246 | 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 (3)
- EUDAMED 1ac141f2-893b-42dd-b236-26b6f36b977b 61 fields · synced Jul 19, 2026
- EUDAMED e10977e9-4e38-4474-bc39-1471a1a27f5e 61 fields · synced May 19, 2026
- FDA UDI 4d9728c9-90df-4a16-b566-cbb3fbb98e1d 34 fields · synced May 30, 2026