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Sterile Hypodermic Needles for Single Use
EUDAMEDClass IIa (EU MDR)
Ref HD2180Model TWSB
Identity
- Trade Name
- Sterile Hypodermic Needles for Single Use EUDAMED
- Device Name
- Sterile Hypodermic Needles for Single Use EUDAMED
- Model / Reference
- TWSB EUDAMEDHD2180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935550811049 EUDAMED
- Basic UDI-DI
- 69355508PXZSZ001U2 EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS 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 Hypodermic Needles for Single Use by Jiangsu Shenli Medical Production 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 | 69355508PXZSZ001U2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Shenli Medical Production Co., Ltd.
- EUDAMED SRN
- CN-MF-000029176
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b8fe1b87-9b74-46e4-88a5-37af38fb5984 61 fields · synced Jun 19, 2026