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Sentinel Software V11
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 98201Model Sentinel 11
Identity
- Trade Name
- SENTINEL SOFTWARE V11 EUDAMEDSentinel FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- Sentinel 11 EUDAMEDSENTINEL SOFTWARE V11 FDA UDI
- Model / Reference
- Sentinel 11 EUDAMEDFDA UDI98201 EUDAMED
- Description
- SENTINEL SOFTWARE V11 FDA UDI
Identifiers
- Catalog Number
- 98201 FDA UDI
- Primary DI / UDI-DI
- 10841522125751 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IIa98201OWNGF EUDAMED
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- Z12050482 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1425 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- France 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Sentinel Software V11 by Spacelabs Healthcare 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 | 08415221IIa98201OWNGF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare Ltd
- EUDAMED SRN
- GB-MF-000001196
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 2d1d10e7-10ac-48a4-9909-a3547de44626 61 fields · synced Jun 18, 2026
- FDA UDI 9a771a43-681b-4226-b673-a1847698fb7a 34 fields · synced May 29, 2026