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Barrier Film and Sleeves (Barrier film)
EUDAMEDClass I (EU MDR)
Ref 11-30002Model 11-30001
Identity
- Trade Name
- Barrier Film and Sleeves (Barrier film) EUDAMED
- Device Name
- Barrier Film and Sleeves EUDAMED
- Model / Reference
- 11-30001 EUDAMED11-30002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978726484821 EUDAMED
- Basic UDI-DI
- 69787264811-30001XW EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 (Barrier film) by Jiangsu Yabaobao 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 | 69787264811-30001XW | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Yabaobao Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000048665
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (2)
- EUDAMED 60192886-de3d-4387-84e9-935a19c83b89 61 fields · synced Oct 6, 2026
- EUDAMED 34f318d9-bc04-4c95-b211-3ce370c15d89 61 fields · synced Oct 6, 2026