Identity
- Trade Name
- sterile Infusion connector and accessory EUDAMED
- Device Name
- sterile Infusion connector and accessory EUDAMED
- Model / Reference
- BVC53 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972769414753 EUDAMED
- Basic UDI-DI
- 697276941DR000NFC01ML EUDAMED
- EMDN Code
- A0380 TUBULAR DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
sterile Infusion connector and accessory by Zhuhai DR Medical Instruments 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 | 697276941DR000NFC01ML | Class I | Active |
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Manufacturer
- Manufacturer
- Zhuhai DR Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000021135
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 8b630238-1b13-448d-b399-acd09011a61b 61 fields · synced Jun 19, 2026