← Back to catalogue
Cystoscopy pack
EUDAMEDClass I (EU MDR)
Ref N76D13-OS15IA-B01Model N76D13 O76D13 N76D13-00 N76D13-01 N76D13-02 N76D13-03
Identity
- Device Name
- Cystoscopy pack EUDAMED
- Model / Reference
- N76D13 O76D13 N76D13-00 N76D13-01 N76D13-02 N76D13-03 EUDAMEDN76D13-OS15IA-B01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975197845502 EUDAMED
- Basic UDI-DI
- 697519784Z55WY 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
Cystoscopy pack by Leboo (Hubei) 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 | 697519784Z55WY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leboo (Hubei) Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000021186
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 2a152eaf-7a57-4698-b93d-c9de283fb7ed 61 fields · synced Oct 6, 2026