Identity
- Trade Name
- Eclipse Mini EUDAMEDFDA UDI
- Generic Name
- Electrocardiographic electrode, single-use FDA UDI
- Device Name
- ECLIPSE MINI ECG SENSORS (BOX OF 10) EUDAMEDFDA UDI
- Model / Reference
- Eclipse Mini EUDAMEDFDA UDI712-1053-01 EUDAMED
- Description
- ECLIPSE MINI ECG SENSORS (BOX OF 10) FDA UDI
Identifiers
- Catalog Number
- 712-1053-01 FDA UDI
- Primary DI / UDI-DI
- 10841522130304 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IEMPATCHOWNBU EUDAMED
- FDA Product Code
- DRX FDA UDI
- EMDN Code
- Z12050485 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES EUDAMED
- GMDN Term
- Electrocardiographic electrode, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2360 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Eclipse Mini 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 | 08415221IEMPATCHOWNBU | 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 7870299a-67b0-4b4d-8225-e6224e41c046 61 fields · synced Jul 10, 2026
- FDA UDI e436165d-690d-4012-881b-eff1e3c1bf2e 35 fields · synced May 30, 2026