Identity
- Trade Name
- Isansys EUDAMEDFDA UDI
- Generic Name
- Physiological measuring device wireless data capture/transfer unit FDA UDI
- Device Name
- Patient Status Engine EUDAMEDLifeguard Server - Data Server & remote display FDA UDI
- Model / Reference
- PSE_2 EUDAMEDLifeguard Server EUDAMEDFDA UDI
- Description
- Lifeguard Server - Data Server & remote display FDA UDI
Identifiers
- Catalog Number
- Lifeguard Server FDA UDI
- Primary DI / UDI-DI
- 05060488680175 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048868PSE2EG EUDAMED
- Direct Marketing DI
- 05060488680175 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
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
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 a44d7824-c955-4a3a-8edc-ea26f3e4a30f 61 fields · synced Jul 13, 2026
- FDA UDI f6c06318-3d7f-4d4f-b73a-9944648c8149 35 fields · synced May 30, 2026