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uPAT™ Probe
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC2101300Ref AC2101301Ref AC2101330Ref AC2111303
Identity
- Trade Name
- uPAT™ Probe EUDAMED12 uPAT Probes for Watch-PAT FDA UDI
- Generic Name
- Cardiovascular-risk peripheral arterial tonometry system sensor FDA UDI
- Device Name
- Watch-PAT300 EUDAMED12 uPAT Probes FDA UDI
- Model / Reference
- AC2101300 EUDAMEDAC2101301 EUDAMEDAC2101330 EUDAMEDAC2111303 EUDAMED12 uPAT Probes for Watch-PAT FDA UDI
- Description
- 12 uPAT Probes FDA UDI
Identifiers
- Catalog Number
- AC2101300 FDA UDI
- Primary DI / UDI-DI
- 07290109222103 EUDAMEDFDA UDI07290109223339 EUDAMED07290109223063 EUDAMED07290109223483 EUDAMED
- Basic UDI-DI
- 729010922AC21107M9 EUDAMED
- 510(k) Number
- K133859 FDA UDIK153070 FDA UDIK161579 FDA UDIK180775 FDA UDIK203839 FDA UDIK222331 FDA UDI
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiovascular-risk peripheral arterial tonometry system sensor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Sweden EUDAMEDItaly 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
uPAT™ Probe by Itamar Medical 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 | 729010922AC21107M9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Itamar Medical Ltd.
- EUDAMED SRN
- IL-MF-000012046
- Authorised Representative
- Arazy Group GmbH DE-AR-000007685
Sources (5)
- EUDAMED 516552c4-5da3-44dd-915f-4d80f4d2e998 61 fields · synced Jul 17, 2026
- EUDAMED ec1eeb0f-9199-4dd3-8132-6c6fc8ac973c 61 fields · synced May 18, 2026
- EUDAMED c6975e9d-476a-43cf-8379-de19ff8e3cc9 61 fields · synced May 18, 2026
- EUDAMED f5c1b357-ba08-4228-b2b0-f122108d2520 61 fields · synced May 18, 2026
- FDA UDI 33b1c97b-b6dc-49bd-8698-4c36745ee5af 37 fields · synced May 30, 2026