Identity
- Trade Name
- Disposable Surgical Kits(Universal kit) EUDAMED
- Device Name
- Disposable Surgical Kits(Universal kit) EUDAMED
- Model / Reference
- FJB0035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973866555004 EUDAMED
- Basic UDI-DI
- 697386655FGSKUKYW EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland 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
Disposable Surgical Kits(Universal kit) by Xianning Full Guard Medical Products Co., Ltd. — 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 | 697386655FGSKUKYW | Class I | Active |
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Manufacturer
- Manufacturer
- Xianning Full Guard Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000013685
- Authorised Representative
- Zoustech S.L. ES-AR-000002008
Sources (1)
- EUDAMED 1f2a236b-f262-4858-860c-75426b1c541b 61 fields · synced Oct 6, 2026