Identity
- Trade Name
- WiBU Plus EUDAMED
- Device Name
- Nitrile Disposable Examination Gloves EUDAMED
- Model / Reference
- X3000-L EUDAMED812568 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975016726869 EUDAMED
- Basic UDI-DI
- 697501672X3000L8H EUDAMED
- Direct Marketing DI
- 06975016726869 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
WiBU Plus by Xingyu Medical Tech 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 | 697501672X3000L8H | Class I | Active |
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Manufacturer
- Manufacturer
- Xingyu Medical Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000018326
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (1)
- EUDAMED 8645268a-1834-4561-b4de-35808481324a 61 fields · synced Jun 19, 2026