Identity
- Trade Name
- PRO-DEX Battery Pack EUDAMEDProDriver Battery Pack, Single FDA UDI
- Generic Name
- Disposable battery pack FDA UDI
- Device Name
- PRO-DEX Battery Pack, Single EUDAMED
- Model / Reference
- PDBP-001-2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860540000256 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00860540000256 EUDAMED
- FDA Product Code
- GXL 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
- 882.4900 FDA UDI878.4820 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
PRO-DEX Battery Pack by Pro-Dex, Inc. — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00860540000256 | 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 (2)
- EUDAMED 5189cf3f-2575-4b25-99af-915580a3c721 61 fields · synced Jul 21, 2026
- FDA UDI 653c2ad4-fb9e-4b3c-87f0-63aae184d4d1 32 fields · synced May 30, 2026