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Eclipse Mini Recorder, Multilingual, Loan
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 98900-LModel Eclipse Mini
Identity
- Trade Name
- ECLIPSE MINI RECORDER, MULTILINGUAL,LOAN EUDAMEDEclipse Mini FDA UDI
- Generic Name
- Electrocardiographic ambulatory recorder FDA UDI
- Device Name
- Eclipse Mini EUDAMEDECLIPSE MINI RECORDER, MULTILINGUAL,LOAN FDA UDI
- Model / Reference
- Eclipse Mini EUDAMEDFDA UDI98900-L EUDAMED
- Description
- ECLIPSE MINI RECORDER, MULTILINGUAL,LOAN FDA UDI
Identifiers
- Catalog Number
- 98900-L FDA UDI
- Primary DI / UDI-DI
- 10841522129209 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IIa98900OWNK3 EUDAMED
- Direct Marketing DI
- 10841522129209 EUDAMED
- 510(k) Number
- K212317 FDA UDI
- 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
Eclipse Mini Recorder, Multilingual, Loan 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 | 08415221IIa98900OWNK3 | 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 730cb1ef-29d2-45b1-93af-ea18142e2876 61 fields · synced Aug 1, 2026
- FDA UDI ecea8baa-b173-4cf7-9026-432ea5030d39 36 fields · synced May 29, 2026