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AlphaMed
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 06953825909550Model U83YRef 06953825909949Model U86ERef 06953825908720Model U80CH series, 80H series, U80M series, U80NH series, U81X series, U81RH series, U83Z series, U86E series, U90E series Total: 69 modelsRef 06953825901073Model UFR103Ref 06953825909567Model UFR116Ref 06953825909499Model U80EHRef 06953825911102Model U81V
Identity
- Trade Name
- AlphaMed EUDAMEDFDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- Upper Arm Electronic Blood Pressure Monitor EUDAMEDInfrared Thermometer EUDAMED
- Model / Reference
- U83Y EUDAMED06953825909550 EUDAMEDU86E EUDAMED06953825909949 EUDAMEDU80CH series, 80H series, U80M series, U80NH series, U81X series, U81RH series, U83Z series, U86E series, U90E series Total: 69 models EUDAMED06953825908720 EUDAMEDUFR103 EUDAMEDFDA UDI06953825901073 EUDAMEDUFR116 EUDAMED06953825909567 EUDAMEDU80EH EUDAMED06953825909499 EUDAMEDU81V EUDAMED06953825911102 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953825909550 EUDAMED06953825909949 EUDAMED06953825908720 EUDAMED06953825901073 EUDAMEDFDA UDI06953825909567 EUDAMED06953825909499 EUDAMED06953825911102 EUDAMED
- Basic UDI-DI
- B-06953825909550 EUDAMEDB-06953825909949 EUDAMED69538259UBP8K EUDAMEDB-06953825901073 EUDAMEDB-06953825909567 EUDAMEDB-06953825909499 EUDAMEDB-06953825911102 EUDAMED
- Direct Marketing DI
- 06953825908720 EUDAMED
- 510(k) Number
- K200802 FDA UDI
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMEDZ1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMEDV0301010299 DIGITAL THERMOMETERS - OTHER EUDAMED
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Northern Ireland EUDAMEDItaly 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
EUDAMEDEUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AlphaMed by Shenzhen Urion Technology Co., Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06953825909550 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06953825909550 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Urion Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000018740
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (8)
- EUDAMED 3e39138e-dafe-41db-8da5-ebc6c5a472a2 61 fields · synced Jul 29, 2026
- EUDAMED 65426eea-52e7-4e55-8157-4c011a7328a3 61 fields · synced May 17, 2026
- EUDAMED 7685a71a-10f1-4488-b836-800b61f8556c 61 fields · synced May 18, 2026
- EUDAMED a32a4bad-ab35-497f-9dfa-1cd862563eec 61 fields · synced May 18, 2026
- EUDAMED 3c3592e9-294b-45bf-90e6-2032414c9ff0 61 fields · synced May 18, 2026
- EUDAMED a7f53c01-c476-478e-8af5-2e06ac063c2f 61 fields · synced May 19, 2026
- FDA UDI 28a302c0-6724-41d3-b244-209af9755bfe 33 fields · synced May 30, 2026
- EUDAMED 907ba83c-a24f-432e-a282-4feacb49995b 61 fields · synced Jul 17, 2026