Identity
- Trade Name
- Mini Mat Copper EUDAMEDMini Mat FDA UDI
- Generic Name
- Sterilization packaging, reusable FDA UDI
- Device Name
- Dental Cleaning, Sterilization, Disinfection Accessories EUDAMEDMini Mat Copper EUDAMEDInstrument holder intended for 8 dental instruments for sterilization. FDA UDI
- Model / Reference
- 20Z480U EUDAMED50Z480U EUDAMEDU-Copper FDA UDI
- Description
- Instrument holder intended for 8 dental instruments for sterilization. FDA UDI
Identifiers
- Catalog Number
- 50Z480U FDA UDI
- Primary DI / UDI-DI
- 00840161301222 EUDAMEDD68550Z480U0 FDA UDI
- Basic UDI-DI
- 0840161300083F EUDAMEDB-00840161301222 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 Copper by Zirc Dental Products, Inc. — Class I — MDD, MDR, 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/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 0840161300083F | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0840161300083F | 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 bffa77fd-069f-48c1-8528-c09012ff050d 61 fields · synced Jul 19, 2026
- EUDAMED db012ef1-4336-4afd-9022-04e46ca692ec 61 fields · synced May 17, 2026
- FDA UDI 23da7e17-91f4-4383-8a5d-e84eb0bcde0c 34 fields · synced May 29, 2026