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MatrixPRO II Driver
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 05.000.030Model APD-1000-2
Identity
- Trade Name
- MatrixPRO II Driver EUDAMEDMatrix Pro II Driver FDA UDI
- Generic Name
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
- Device Name
- MatrixPRO II Driver EUDAMED
- Model / Reference
- APD-1000-2 EUDAMED05.000.030 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00856482008023 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856482008APD-1000-XRU EUDAMEDB-00856482008023 EUDAMED
- Direct Marketing DI
- 00856482008023 EUDAMED
- FDA Product Code
- HWE FDA UDIGXL FDA UDIGEY FDA UDI
- EMDN Code
- L26,Z12130503 EUDAMED
- GMDN Term
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI882.4900 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MatrixPRO II Driver by Pro-Dex, Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 0856482008APD-1000-XRU | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0856482008APD-1000-XRU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 737f3593-514a-4b8b-83ed-ed885a574f77 61 fields · synced Jul 9, 2026
- EUDAMED 0651cec7-46c6-492a-aef3-eb81df790e36 61 fields · synced May 19, 2026
- FDA UDI ac05c925-76e1-431a-aa5b-be0fa65f6149 32 fields · synced May 30, 2026