MatrixPRO Driver Battery, Sterile
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- MatrixPRO Driver Battery, Sterile EUDAMEDMatrixPRO Driver Battery Pack, Sterile FDA UDI
- Generic Name
- Disposable battery pack FDA UDI
- Device Name
- MatrixPRO Driver Battery, Sterile EUDAMED
- Model / Reference
- SYN-BP-001S EUDAMED05.000.021S EUDAMEDFDA UDISYN-BP-XXXS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00862377000119 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00862377000119 EUDAMED0856482008SYN-BP-XXXSEE EUDAMED
- FDA Product Code
- GEY FDA UDIGXL FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Disposable battery pack FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
MatrixPRO Driver Battery, Sterile by Pro-Dex, Inc. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00862377000119 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00862377000119 | 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 31de79ff-7a83-4420-9c5c-8df11e13fdbb 61 fields · synced Sep 17, 2026
- EUDAMED 21199654-d2c6-4ca9-8f74-0f726b145f80 61 fields · synced May 19, 2026
- FDA UDI 4d1f44c6-2f1e-45de-85bc-91e48322d2e1 32 fields · synced May 30, 2026