Identity
- Trade Name
- External Battery Pack with Packaging EUDAMEDNatus FDA UDI
- Generic Name
- Noninvasive device battery charger FDA UDI
- Device Name
- Quantum II Class I Accessories EUDAMEDExternal Battery Pack with packaging FDA UDI
- Model / Reference
- 021255 EUDAMEDFDA UDI
- Description
- External Battery Pack with packaging FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00382830059268 EUDAMEDFDA UDI
- Basic UDI-DI
- 038283NA00057EG EUDAMED
- Direct Marketing DI
- 00382830059268 EUDAMED
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES EUDAMED
- GMDN Term
- Noninvasive device battery charger FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Ireland 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
External Battery Pack with Packaging by Natus Medical Incorporated Dba Excel-Tech Ltd (xltek) — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038283NA00057EG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- CA-MF-000004001
- Authorised Representative
- Natus Manufacturing Ltd IE-AR-000000884
Sources (2)
- EUDAMED 7129044c-8bd9-4cbb-90d9-1a95c8576fa6 61 fields · synced Oct 6, 2026
- FDA UDI 9809ee57-33f4-4a1c-a863-e92e609c7b40 33 fields · synced May 30, 2026