Identity
- Trade Name
- Endo-boot protector sponge EUDAMED
- Device Name
- Disposable Distal Tip Protectors EUDAMED
- Model / Reference
- EP-14-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936603201213 EUDAMED
- Basic UDI-DI
- 697090085102789 EUDAMED
- Direct Marketing DI
- 06936603201213 EUDAMED
- EMDN Code
- G0399 DIGESTIVE ENDOSCOPY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Endo-boot protector sponge by Yangzhou Fartley Medical Instrument Technology 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 | 697090085102789 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000009371
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED beb7ff51-7e59-4f66-9a29-f5d38065b0be 61 fields · synced Oct 6, 2026