Identity
- Trade Name
- Sterile Syringes for Single Use EUDAMED
- Device Name
- Sterile Syringes for Single Use EUDAMED
- Model / Reference
- S301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949236213256 EUDAMED
- Basic UDI-DI
- 69492362S002RK EUDAMED
- EMDN Code
- A020102010102 INFUSION AND IRRIGATION SYRINGES, 2-PIECE LUER CONE, 2-PIECE WITHOUT NEEDLE, SINGLE-USE 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Syringes for Single Use by Berpu Medical 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 | 69492362S002RK | Class I | Active |
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Manufacturer
- Manufacturer
- Berpu Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000012430
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 506bca93-33d6-4336-ba0a-6ae7ce9f5716 61 fields · synced May 23, 2026