MatrixPRO II Single Use Battery
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- MatrixPRO II Single Use Battery EUDAMEDMatrix Pro II Single Use Battery FDA UDI
- Generic Name
- Disposable battery pack FDA UDI
- Device Name
- MatrixPRO II Single Use Battery EUDAMED
- Model / Reference
- APD-BP-010S-2 EUDAMED05.000.031S EUDAMEDFDA UDIAPD-BP-XXXS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00856482008030 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00856482008030 EUDAMED0856482008APD-BP-XXXS-XBM EUDAMED
- FDA Product Code
- HWE FDA UDIGXL FDA UDIGEY 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 II Single Use Battery 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-00856482008030 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00856482008030 | 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 6e2f2f79-b361-4066-a4c7-a66f93c4071c 61 fields · synced Jul 17, 2026
- EUDAMED b5a1c7ab-7fc6-4996-a594-218670c6573f 61 fields · synced May 17, 2026
- FDA UDI d2f8bd2f-044d-4e35-9e7d-d83f0bf558cd 32 fields · synced May 29, 2026