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Sterile Disposable Acupuncture Needle
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref Sterile Disposable Acupuncture Needle
Identity
- Device Name
- Sterile Disposable Acupuncture Needle EUDAMED
- Model / Reference
- Sterile Disposable Acupuncture Needle EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-880911871HS0001A6GM EUDAMED
- Basic UDI-DI
- B-880911871HS0001A6GM 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Disposable Acupuncture Needle by Hansol Medical Co. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090910 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-880911871HS0001A6GM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hansol Medical Co.
- EUDAMED SRN
- KR-MF-000023984
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (2)
- EUDAMED ba1772d5-bb21-477c-86e8-4b820c8382a6 61 fields · synced Oct 6, 2026
- FDA 510(k) K090910 1 fields · synced May 18, 2026