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Cuff, Abp, Child, 12-20cm/5-8in, No Ltx
EUDAMEDFDA UDIClass I (EU MDR)
Ref 015-0118-05QModel ABP Cuffs and Cuff Covers
Identity
- Trade Name
- CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX EUDAMEDOntrak FDA UDI
- Generic Name
- Blood pressure ambulatory recorder FDA UDI
- Device Name
- ABP Cuffs and Cuff Covers EUDAMEDCUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX FDA UDI
- Model / Reference
- ABP Cuffs and Cuff Covers EUDAMEDFDA UDI015-0118-05Q EUDAMED
- Description
- CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX FDA UDI
Identifiers
- Catalog Number
- 015-0118-05Q FDA UDI
- Primary DI / UDI-DI
- 10841522129247 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IABPCUFFOWN2D EUDAMED
- 510(k) Number
- K141113 FDA UDI
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020599 NON-INVASIVE BLOOD PRESSURE GAUGES - OTHER EUDAMED
- GMDN Term
- Blood pressure ambulatory recorder FDA UDI
Classification
- Device Class
- Class I 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cuff, Abp, Child, 12-20cm/5-8in, No Ltx by Spacelabs Healthcare 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 | 08415221IABPCUFFOWN2D | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 d9742c06-dff6-44f7-94ba-cf55f4d15cfc 61 fields · synced Jul 17, 2026
- FDA UDI 5b0557d3-ba17-405c-a243-5a7cc6b5ff3f 36 fields · synced May 25, 2026