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MatrixPRO Driver Graphic Case
EUDAMEDFDA UDIClass I (EU MDR)
Ref 60.000.010Model SYN-SC-001
Identity
- Trade Name
- MatrixPRO Driver Graphic Case EUDAMEDMatrixPro sterilization case FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Graphic Case EUDAMEDMatrixPRO Driver Graphic Case EUDAMED
- Model / Reference
- 60.000.010 EUDAMEDFDA UDISYN-SC-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860540000201 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856482008SYN_APD-SC-XXHH EUDAMEDB-00860540000201 EUDAMED
- Direct Marketing DI
- 00860540000201 EUDAMED
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Belgium 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument tray, reusable
MatrixPRO Driver Graphic Case by Pro-Dex, 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 | 0856482008SYN_APD-SC-XXHH | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0856482008SYN_APD-SC-XXHH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pro-Dex, Inc.
- EUDAMED SRN
- US-MF-000010685
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (3)
- EUDAMED 7332cc9a-17a5-4b76-953a-1a4a123fc9ca 61 fields · synced Jun 20, 2026
- EUDAMED b16b22f2-f170-4d67-9ee9-625171c972b5 61 fields · synced May 17, 2026
- FDA UDI ca0b83c6-a5b0-43f3-ad50-211c61912988 32 fields · synced May 29, 2026