Identity
- Trade Name
- E-LINK EUDAMEDBiometrics Ltd Pinchmeter FDA UDI
- Generic Name
- Hand dynamometer/pinchmeter, electronic FDA UDI
- Device Name
- E-LINK Evaluation and Exercise Systems EUDAMEDThe unique electronic pinchmeter has a low profile design that enables the researcher to accurately quantify pinch strength at closer to end range than any other device. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013. FDA UDI
- Model / Reference
- P200 Pinchmeter EUDAMEDP200 FDA UDI
- Description
- The unique electronic pinchmeter has a low profile design that enables the researcher to accurately quantify pinch strength at closer to end range than any other device. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060481690034 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048169E-LINKY3 EUDAMED
- FDA Product Code
- HCC FDA UDIISD FDA UDIIKK FDA UDI
- EMDN Code
- Z12040199 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Hand dynamometer/pinchmeter, electronic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI890.5360 FDA UDI890.1925 FDA UDI
- Market of Registration
- Northern 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
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
E-Link by Biometrics Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 506048169E-LINKY3 | 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 (2)
- EUDAMED 5b1c5386-a5ac-4b96-bc9c-faf23072ffd0 61 fields · synced Jul 9, 2026
- FDA UDI f1571ee4-db3c-479e-9bc3-11ce78419c2b 33 fields · synced May 30, 2026