Identity
- Trade Name
- WatchPAT™ Tamper Proof Bracelet EUDAMEDTamper-Proof Bracelets (24) for Watch-PAT200 and Watch-PAT200U FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Tamper-Proof Bracelet for WatchPAT EUDAMEDTamper-Proof Bracelets (24), WatchPAT FDA UDI
- Model / Reference
- AC2000300 EUDAMEDTamper-Proof Bracelets (24) for Watch-PAT200 and Watch-PAT200U FDA UDI
- Description
- Tamper-Proof Bracelets (24), WatchPAT FDA UDI
Identifiers
- Catalog Number
- AC2000300 FDA UDI
- Primary DI / UDI-DI
- 07290109222837 EUDAMEDFDA UDI
- Basic UDI-DI
- 729010922AC20003LM 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
WatchPAT™ Tamper Proof Bracelet 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 | 729010922AC20003LM | 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 00443c49-c006-4d20-a770-4c12cf5d36d5 61 fields · synced Jul 24, 2026
- FDA UDI 0fa84431-6226-45e0-bbb9-77c93f18b005 36 fields · synced May 30, 2026