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Eclipse Pro, Defib Cable, Px, 3 Snap, Short
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 700-0392-00Model Eclipse Pro cables and patches
Identity
- Trade Name
- ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,SHORT EUDAMEDEclipse Pro FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Eclipse Pro cables and patches EUDAMEDECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,SHORT FDA UDI
- Model / Reference
- Eclipse Pro cables and patches EUDAMED700-0392-00 EUDAMEDEclipse Pro FDA UDI
- Description
- ECLIPSE PRO,DEFIB CABLE,PX,3 SNAP,SHORT FDA UDI
Identifiers
- Catalog Number
- 700-0392-00 FDA UDI
- Primary DI / UDI-DI
- 10841522129698 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415221IEPROC&POWN7U EUDAMED
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050485 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - CONSUMABLES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I 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
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
Eclipse Pro, Defib Cable, Px, 3 Snap, Short by Spacelabs Healthcare Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211651 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 08415221IEPROC&POWN7U | Class I | Active |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare Ltd
- EUDAMED SRN
- GB-MF-000001196
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (3)
- EUDAMED 43527973-38a3-48d1-b95d-0e66836a0206 61 fields · synced Jul 19, 2026
- FDA UDI f18edb8c-fd3b-4bf2-92ec-3ff5b3b1338b 34 fields · synced May 30, 2026
- FDA 510(k) K211651 1 fields · synced May 18, 2026