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Eclipse Pro Recorder, Multilingual
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 98700Model Eclipse Pro
Identity
- Trade Name
- ECLIPSE PRO RECORDER,MULTILINGUAL EUDAMEDEclipse Pro FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Eclipse Pro EUDAMEDECLIPSE PRO RECORDER,MULTILINGUAL FDA UDI
- Model / Reference
- Eclipse Pro EUDAMEDFDA UDI98700 EUDAMED
- Description
- ECLIPSE PRO RECORDER,MULTILINGUAL FDA UDI
Identifiers
- Catalog Number
- 98700 FDA UDI
- Primary DI / UDI-DI
- 10841522128851 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IIa98700OWNJ9 EUDAMED
- Direct Marketing DI
- 10841522128851 EUDAMED
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050403 ECG HOLTER RECORDERS EUDAMED
- GMDN Term
- Electrocardiographic ambulatory recorder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 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
MR Unsafe FDA UDI
Eclipse Pro Recorder, Multilingual 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 | 08415221IIa98700OWNJ9 | 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 7129146e-412d-4db7-b5fe-d77d72ac53a3 61 fields · synced Jun 18, 2026
- FDA UDI 9b469c42-c056-4f63-a0a0-88d64ae345d2 35 fields · synced May 30, 2026