Identity
- Trade Name
- Sterile Silicone Cap EUDAMED
- Device Name
- Silicone Cap EUDAMED
- Model / Reference
- 9.7*15.1mm EUDAMED9060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974194580393 EUDAMED
- Basic UDI-DI
- 697419458JXCE002YT EUDAMED
- EMDN Code
- T030101,T030301 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
Sterile Silicone Cap by Ningbo JianXiang Packaging Material 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 | 697419458JXCE002YT | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010447
- Authorised Representative
- phoenix Medtech GmbH DE-AR-000007996
Sources (1)
- EUDAMED 457b0608-5679-4164-8db7-d49d7393284e 61 fields · synced Jul 23, 2026