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Isansys
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Gateway SM-X205 GSMModel PSE_2Ref Lifetouch NeonateRef Lifetouch Neonate SnapRef Lifetemp Sensor - V2 - MediumRef Lifetouch Sensor - LargeRef Lifetouch Small
Identity
- Trade Name
- Isansys EUDAMEDFDA UDIPatient Gateway FDA UDI
- Generic Name
- Physiological measuring device wireless data capture/transfer unit FDA UDI
- Device Name
- Patient Status Engine EUDAMEDContinuous Cardiac Sensor FDA UDIContinuous Clinical Thermometer FDA UDISM-X205 - 10.5 Screen - GSM Data entry & local display point tablet computer, 10.5 Screen FDA UDI
- Model / Reference
- PSE_2 EUDAMEDGateway SM-X205 GSM EUDAMEDLifetouch Neonate EUDAMEDLifetouch Neonate Snap EUDAMEDLifetouch Sensor - Large EUDAMEDFDA UDILifetemp Sensor - V2 - Medium EUDAMEDFDA UDILifetouch Small EUDAMEDSM-X205 - 10.5 Screen - GSM FDA UDILifetouch Sensor - Small FDA UDI
- Description
- Continuous Cardiac Sensor FDA UDIContinuous Clinical Thermometer FDA UDISM-X205 - 10.5 Screen - GSM Data entry & local display point tablet computer, 10.5 Screen FDA UDI
Identifiers
- Catalog Number
- Lifetouch Sensor - Large FDA UDILifetemp Sensor - V2 - Medium FDA UDIGateway SM-X205 GSM FDA UDILifetouch Sensor - Small FDA UDI
- Primary DI / UDI-DI
- 05060488680311 EUDAMEDFDA UDI05060488680076 EUDAMED05060488680083 EUDAMED05060488680113 EUDAMEDFDA UDI05060488680281 EUDAMEDFDA UDI05060488680090 EUDAMEDFDA UDI
- Basic UDI-DI
- 506048868PSE2EG EUDAMED
- Direct Marketing DI
- 05060488680311 EUDAMED05060488680076 EUDAMED05060488680083 EUDAMED05060488680281 EUDAMED05060488680113 EUDAMED05060488680090 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 UDIFDA 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 UDIFDA 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 (10)
- EUDAMED 30013ad0-cf99-4867-bbb0-d4ae694f8ee6 61 fields · synced Sep 17, 2026
- EUDAMED 1aa29fb8-390b-4066-a95b-e577d8d8634d 61 fields · synced May 17, 2026
- EUDAMED 306488e0-8712-4895-b07a-4eed9676ca6c 61 fields · synced May 18, 2026
- FDA UDI 0fae0fb6-a08f-4e59-a980-46033e074af2 35 fields · synced May 29, 2026
- FDA UDI 9cdb2fef-fe7d-42ae-b8e5-72dd366017df 35 fields · synced May 29, 2026
- FDA UDI 1890d395-2762-433a-85cb-e5b293b436d1 35 fields · synced May 30, 2026
- FDA UDI 99efdc76-e08d-435c-b4ea-d93540a241f2 35 fields · synced May 30, 2026
- EUDAMED 00551bad-6af1-4687-89df-82e0704bf86a 61 fields · synced Jul 8, 2026
- EUDAMED 1cc616ec-d223-4505-9eff-01a1d2280f4e 61 fields · synced Jul 11, 2026
- EUDAMED 21ab8a0c-6cba-40a1-b3f0-4252d05048dd 61 fields · synced Jul 20, 2026