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300/LP110/005-3 Life Pulse 10 ECG Monitor suspension
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 300/LP110/005-3
Identity
- Trade Name
- 300/LP110/005-3 Life Pulse 10 ECG Monitor suspension EUDAMEDKENEX FDA UDI
- Generic Name
- Radiation shielding panel, fixed FDA UDI
- Device Name
- Overhead suspended radiation shields (with or without lights) EUDAMED300/LP110/005-3 Life Pulse 10 ECG Monitor suspension FDA UDI
- Model / Reference
- 300/LP110/005-3 EUDAMEDFDA UDI
- Description
- 300/LP110/005-3 Life Pulse 10 ECG Monitor suspension FDA UDI
Identifiers
- Catalog Number
- 300/LP110/005-3 FDA UDI
- Primary DI / UDI-DI
- 05055449400503 EUDAMEDFDA UDI
- Basic UDI-DI
- 50554494SHOXP EUDAMED
- Direct Marketing DI
- 05055449400503 EUDAMED
- FDA Product Code
- EAK FDA UDI
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
- GMDN Term
- Radiation shielding panel, fixed FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
300/LP110/005-3 Life Pulse 10 ECG Monitor suspension by Kenex (electro-Medical) Limited — 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 | K832160 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 50554494SHOXP | Class I | Active |
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Manufacturer
- Manufacturer
- Kenex (Electro-Medical) Limited
- EUDAMED SRN
- GB-MF-000009022
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED ecc43005-4a7b-4c00-80d2-57423686051a 61 fields · synced Jun 18, 2026
- FDA UDI 6d46ed44-81f1-422a-89f9-1ef9a8e936ba 34 fields · synced May 30, 2026
- FDA 510(k) K832160 1 fields · synced May 18, 2026