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Pathfinder Sl Holter Analysis System (english)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 98000-01Model Pathfinder SL
Identity
- Trade Name
- PATHFINDER SL HOLTER ANALYSIS SYSTEM (ENGLISH) EUDAMEDPathfinder SL FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- Pathfinder SL EUDAMEDPATHFINDER SL HOLTER ANALYSIS SYSTEM (ENGLISH) FDA UDI
- Model / Reference
- Pathfinder SL EUDAMEDFDA UDI98000-01 EUDAMED
- Description
- PATHFINDER SL HOLTER ANALYSIS SYSTEM (ENGLISH) FDA UDI
Identifiers
- Catalog Number
- 98000-01 FDA UDI
- Primary DI / UDI-DI
- 10841522126000 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IIa98000OWNFE EUDAMED
- FDA Product Code
- DQK FDA UDI
- EMDN Code
- Z12050401 CARDIOVASCULAR HOLTER ANALYSERS EUDAMED
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser 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
Yes
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
Pathfinder Sl Holter Analysis System (english) by Spacelabs Healthcare Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 08415221IIa98000OWNFE | 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 81f96ffb-bca8-426a-b1c9-de29ad6f4115 61 fields · synced Jun 18, 2026
- FDA UDI fe418976-4b0c-4927-bf79-222f356e59bf 34 fields · synced May 30, 2026