Identity
- Trade Name
- 12 Adhesive Foam Disk 2side Itamar SBP for Watch-PAT200S3, Watch-PAT200U FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Adhesive Foam for SBP/RESBP EUDAMED12 Adhesive Foam Disk 2side For Itamar SBP/RESBP FDA UDI
- Model / Reference
- AC2000110 EUDAMED12 Adhesive Foam Disk 2side Itamar SBP for Watch-PAT200S3, Watch-PAT200U FDA UDI
- Description
- 12 Adhesive Foam Disk 2side For Itamar SBP/RESBP FDA UDI
Identifiers
- Catalog Number
- AC2000110 FDA UDI
- Primary DI / UDI-DI
- 07290109222813 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010922AC20001LH EUDAMED
- FDA Product Code
- MNR FDA UDI
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Market of Registration
- Sweden 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
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Adhesive Foam for SBP/RESBP by Itamar Medical Ltd — Class I — 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 | 729010922AC20001LH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (2)
- EUDAMED 1f7904b3-ad3f-4fa1-9b4b-77a93086c1ed 61 fields · synced Jun 18, 2026
- FDA UDI 3c565aff-2634-4fc6-bb5a-1a2876b47361 35 fields · synced May 30, 2026