Identity
- Trade Name
- E-LINK EUDAMEDCA1 Battery Charger EUDAMEDE-LINK CA1 Battery Charger FDA UDI
- Generic Name
- Medical networking interface unit FDA UDI
- Device Name
- E-LINK Accessories EUDAMEDMains powered battery charging unit for up to 4 wireless E-LINK sensors (GX5, NC6, AD1). Includes Medical Grade Power Supply and country specific mains power cord..This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
- Model / Reference
- CA1 Battery Charger EUDAMEDCA1 FDA UDI
- Description
- Mains powered battery charging unit for up to 4 wireless E-LINK sensors (GX5, NC6, AD1). Includes Medical Grade Power Supply and country specific mains power cord..This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690201 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169AccessoriesRBSY EUDAMED
- FDA Product Code
- ION FDA UDIBXB FDA UDIISD FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical networking interface unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5370 FDA UDI890.5380 FDA UDI890.5360 FDA UDI
- Market of Registration
- Northern Ireland EUDAMEDMalta 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
E-Link by Biometrics Ltd — Class I — MDR, 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/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506048169AccessoriesRBSY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biometrics Ltd
- EUDAMED SRN
- GB-MF-000002774
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 9bcff6cb-a3be-43a9-a0c1-12b20fac203e 61 fields · synced Jul 12, 2026
- FDA UDI 49054bcf-1225-4ae8-a3e4-5a8cbdc502b0 33 fields · synced May 30, 2026
- EUDAMED 1a5acca8-7545-4678-a1b5-fbca62f81e00 61 fields · synced Jul 12, 2026