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Sterile single-use acupuncture needle
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0.20*75
Identity
- Trade Name
- Hansol Medical Co. FDA UDI
- Generic Name
- Acupuncture needle, single-use FDA UDI
- Device Name
- Sterile single-use acupuncture needle EUDAMED
- Model / Reference
- 0.20*75 EUDAMED0.20mm x 75mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809118710953 EUDAMEDFDA UDI
- Basic UDI-DI
- 880911871HS0001A6GM EUDAMED
- FDA Product Code
- MQX FDA UDI
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES EUDAMED
- GMDN Term
- Acupuncture needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5580 FDA UDI
- Market of Registration
- Greece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sterile single-use acupuncture needle by Hansol Medical Co. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 880911871HS0001A6GM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 64cb5660-07c0-41c6-9d21-b06e0c004b3f 61 fields · synced Jul 16, 2026
- FDA UDI 32075edd-482f-41b0-9f8b-132127c0451c 32 fields · synced May 29, 2026