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90227, Ontrak (tummel)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 90227-1Model On-Trak
Identity
- Trade Name
- 90227, ONTRAK (TUMMEL) EUDAMEDABP FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Device Name
- On-Trak EUDAMEDABP ONTRAK MONITOR, MULTI-LINGUAL FDA UDI
- Model / Reference
- On-Trak EUDAMED90227-1 EUDAMED90227 FDA UDI
- Description
- ABP ONTRAK MONITOR, MULTI-LINGUAL FDA UDI
Identifiers
- Catalog Number
- 90227-1 FDA UDI
- Primary DI / UDI-DI
- 10841522123177 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IIa90227OWNE7 EUDAMED
- Direct Marketing DI
- 10841522123177 EUDAMED
- 510(k) Number
- K141113 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z12050404 BLOOD PRESSURE HOLTER RECORDERS EUDAMED
- GMDN Term
- Blood pressure ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
90227, Ontrak (tummel) 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 | 08415221IIa90227OWNE7 | 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 d8a3d17a-0533-40f2-86b0-e2c7581dd710 61 fields · synced Jun 18, 2026
- FDA UDI 1a80db07-bb3b-4503-86cf-033e4c60e055 36 fields · synced May 30, 2026