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Sterile Acupuncture Needles
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SA000451EModel Needle body Diameter× Needle body Length, Needle body Diameter:Φ0.13mm-Φ0.80mm,diameter interval 0.01mm, Needle body Length:7mm-150mm, length interval 1mm510(k) K090199Ref SB000451E
Identity
- Trade Name
- Sterile Acupuncture Needles EUDAMED
- Device Name
- Sterile Acupuncture Needles EUDAMED
- Model / Reference
- Needle body Diameter× Needle body Length, Needle body Diameter:Φ0.13mm-Φ0.80mm,diameter interval 0.01mm, Needle body Length:7mm-150mm, length interval 1mm EUDAMEDSA000451E EUDAMEDSB000451E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972011713887 EUDAMED
- Basic UDI-DI
- 697201171C0000003GF EUDAMED
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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 by Wuxi Jiajian Medical Instrument 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 | K090199 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697201171C0000003GF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wuxi Jiajian Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000012006
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (3)
- EUDAMED 3ae02391-62ff-4ce7-be4f-b4c3af39dc13 85 fields · synced Oct 7, 2026
- EUDAMED d02c0a29-d714-4cf8-bd7c-212bae3c9cb0 61 fields · synced Jun 18, 2026
- FDA 510(k) K090199 1 fields · synced May 18, 2026