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Sterile Surgical Packs
EUDAMEDClass I (EU MDR)
Ref N76J06Model N76M01、N76B02、N76H03、N76H04、N76J06、N76A09、N76C08、N76E10Ref N76M01Ref N76H03
Identity
- Device Name
- Sterile Surgical Packs EUDAMED
- Model / Reference
- N76M01、N76B02、N76H03、N76H04、N76J06、N76A09、N76C08、N76E10 EUDAMEDN76J06 EUDAMEDN76M01 EUDAMEDN76H03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975197843003 EUDAMED06975197843027 EUDAMED06975197843010 EUDAMED
- Basic UDI-DI
- 697519784Z23WK EUDAMED
- EMDN Code
- V030203 OPHTHALMOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES EUDAMEDV030299 DIMENSIONAL CLINICAL PARAMETERS MEASURING DEVICES - OTHER EUDAMEDV030205 OBSTETRICS AND GYNECOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES 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
Sterile Surgical Packs 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 | 697519784Z23WK | Class I | Active |
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Manufacturer
- Manufacturer
- Leboo (Hubei) Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000021186
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (3)
- EUDAMED 53bd3adb-44cf-4a69-a308-87862ed0d38c 61 fields · synced Oct 8, 2026
- EUDAMED cad5bc0f-4598-4195-9323-4348c0d0b4f0 61 fields · synced May 17, 2026
- EUDAMED 875d9f89-911a-4e2b-908d-10478a5da1cc 61 fields · synced May 17, 2026