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Sterile Acupuncture Needles for Single Use
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref AK-0.18×30mmModel 0.18×30mm, 0.25×13mm, 0.25×25mm, 0.30×25mm, 0.30×30mm, 0.30×40mm, 0.30×50mm, 0.30×75mm510(k) K162566
Identity
- Device Name
- Sterile Acupuncture Needles for Single Use EUDAMED
- Model / Reference
- 0.18×30mm, 0.25×13mm, 0.25×25mm, 0.30×25mm, 0.30×30mm, 0.30×40mm, 0.30×50mm, 0.30×75mm EUDAMEDAK-0.18×30mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977427145000 EUDAMED
- Basic UDI-DI
- 697168527ZJZ001WQ EUDAMED
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES 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 Acupuncture Needles for Single Use by Changchun Aik Medical Devices Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162566 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697168527ZJZ001WQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changchun AiK Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000026736
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (2)
- EUDAMED 1e491b9c-dc21-4937-b193-d0886dfa0673 85 fields · synced Jun 18, 2026
- FDA 510(k) K162566 1 fields · synced May 18, 2026