Identity
- Trade Name
- Sterile Catheter Sheath Sets EUDAMED
- Device Name
- Sterile Catheter Sheath Sets EUDAMED
- Model / Reference
- QA040050A21NOP1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06927741072346 EUDAMED
- Basic UDI-DI
- 69277410ZBT0009053GL EUDAMED
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
Classification
- Device Class
- Class IIa 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 Catheter Sheath Sets by Zhejiang Barty Medical Technology Co., Ltd. — Class IIa — 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 | 69277410ZBT0009053GL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Barty Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000007977
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED a294acfc-a0be-48bf-8641-95f0246b9e79 61 fields · synced Jun 19, 2026