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N76e03-Oe001
EUDAMEDClass I (EU MDR)
Ref N76E03-OE001Model Pacemaker Pack with Dual Apertures
Identity
- Model / Reference
- Pacemaker Pack with Dual Apertures EUDAMEDN76E03-OE001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424842529 EUDAMED
- Basic UDI-DI
- 697442484L61QR EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
N76e03-Oe001 by Leboo Healthcare Products Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697442484L61QR | Class I | Active |
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Manufacturer
- Manufacturer
- Leboo Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000008521
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 346f9797-f679-4720-9502-9dcbb579b656 61 fields · synced Oct 7, 2026