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Sterile Hypodermic Needles for Single Use
EUDAMEDClass IIa (EU MDR)
Ref TD-HN-0.5mmModel TD-HN
Identity
- Device Name
- Sterile Hypodermic Needles for Single Use EUDAMED
- Model / Reference
- TD-HN EUDAMEDTD-HN-0.5mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945632026025 EUDAMED
- Basic UDI-DI
- 69456320HN001K3 EUDAMED
- Direct Marketing DI
- 06945632026025 EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa 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 Hypodermic Needles for Single Use by Changzhou Tongda Medical Appliance 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 | 69456320HN001K3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Tongda Medical Appliance Co., Ltd.
- EUDAMED SRN
- CN-MF-000027398
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED ef9574a4-91be-480d-8218-b0222e12fa7c 61 fields · synced Oct 6, 2026