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Isansys
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Lifetemp Sensor - V2 - LargeModel PSE_2
Identity
- Trade Name
- Isansys EUDAMEDFDA UDI
- Generic Name
- Physiological measuring device wireless data capture/transfer unit FDA UDI
- Device Name
- Patient Status Engine EUDAMEDContinuous Clinical Thermometer FDA UDI
- Model / Reference
- PSE_2 EUDAMEDLifetemp Sensor - V2 - Large EUDAMEDFDA UDI
- Description
- Continuous Clinical Thermometer FDA UDI
Identifiers
- Catalog Number
- Lifetemp Sensor - V2 - Large FDA UDI
- Primary DI / UDI-DI
- 05060488680298 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048868PSE2EG EUDAMED
- Direct Marketing DI
- 05060488680298 EUDAMED
- 510(k) Number
- K172329 FDA UDI
- FDA Product Code
- DRG FDA UDI
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMED
- GMDN Term
- Physiological measuring device wireless data capture/transfer unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Isansys by Isansys Lifecare, Ltd. — Class IIa — 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 | 506048868PSE2EG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Isansys Lifecare Ltd
- EUDAMED SRN
- GB-MF-000022154
- Authorised Representative
- Isansys Lifecare Europe GmbH DE-AR-000009967
Sources (2)
- EUDAMED 5732e947-cafe-46ce-ad7f-30558a2ee485 61 fields · synced Jul 12, 2026
- FDA UDI 9f7d99ce-4327-40bc-bb64-62c03dbe0fc1 35 fields · synced May 30, 2026