Identity
- Device Name
- Barrier Film and Sleeves EUDAMED
- Model / Reference
- BF1018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976475123008 EUDAMED
- Basic UDI-DI
- 697647512BF001DM EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
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
Barrier Film and Sleeves by Changzhou Shengkang Medical Instrument 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 | 697647512BF001DM | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Shengkang Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000035829
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 04d959be-90cb-442d-a253-67e06385644b 61 fields · synced Oct 6, 2026