← Back to catalogue
N76i01-Os15ia-B00
EUDAMEDClass I (EU MDR)
Ref N76I01-OS15IA-B00Model Gynecology Pack with Abdo-Perineal combined、Gynecology General Pack
Identity
- Model / Reference
- Gynecology Pack with Abdo-Perineal combined、Gynecology General Pack EUDAMEDN76I01-OS15IA-B00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424848361 EUDAMED
- Basic UDI-DI
- 697442484L70QS 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
N76i01-Os15ia-B00 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 | 697442484L70QS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leboo Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000008521
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 53367aef-076f-42e3-8126-d786bc188cfd 61 fields · synced Oct 7, 2026