← Back to catalogue

Non Dolens

EUDAMED

Class IIa (EU MDR)

Ref ND19XP-025×30Model 0.16×15mm,0.16×30mm,0.18×15mm,0.18×30mm,0.20×15mm,0.20×30mm,0.20×40mm,0.22×25mm,0.25×25mm,0.25×30mm,0.25×40mm,0.30×40mm,0.30×25mm,0.30×30mm,0.30×50mm,0.40×25mm,0.40×40mm,0.40×60mm,0.20×13mm,0.20×25mm,0.25×40mm,0.30×40mm,0.30×25mmRef ND18-025×25Model 0.16×15mm,0.16×30mm,0.18×13mm, 0.18×15mm,0.18×30mm,0.20×15mm, 0.20×25mm, 0.20×30mm, 0.20×40mm,0.22×25mm,0.22×40mm,0.25×15mm,0.25×50mm,0.30×15mm,0.25×25mm, 0.25×30mm, 0.25×40mm, 0.30×30mm, 0.30×40mm, 0.30×50mm, 0.30×75mm, 0.35×75mmRef ND18-020×30Ref ND19XP-040×40Ref ND19XP-016×15Ref ND19XP-025×40Ref ND18-018×13Ref ND18-030×75Ref ND19XP-018×30Ref ND18-030×30Ref ND18-025×30Ref ND18-020×15Ref ND18-030×40

by Changchun AiK Medical Devices Co., Ltd.

Identity

Trade Name
Non Dolens EUDAMED
Device Name
Sterile Acupuncture Needles for Single Use EUDAMED
Model / Reference
0.16×15mm,0.16×30mm,0.18×15mm,0.18×30mm,0.20×15mm,0.20×30mm,0.20×40mm,0.22×25mm,0.25×25mm,0.25×30mm,0.25×40mm,0.30×40mm,0.30×25mm,0.30×30mm,0.30×50mm,0.40×25mm,0.40×40mm,0.40×60mm,0.20×13mm,0.20×25mm,0.25×40mm,0.30×40mm,0.30×25mm EUDAMED
ND19XP-025×30 EUDAMED
0.16×15mm,0.16×30mm,0.18×13mm, 0.18×15mm,0.18×30mm,0.20×15mm, 0.20×25mm, 0.20×30mm, 0.20×40mm,0.22×25mm,0.22×40mm,0.25×15mm,0.25×50mm,0.30×15mm,0.25×25mm, 0.25×30mm, 0.25×40mm, 0.30×30mm, 0.30×40mm, 0.30×50mm, 0.30×75mm, 0.35×75mm EUDAMED
ND18-025×25 EUDAMED
ND18-020×30 EUDAMED
ND19XP-040×40 EUDAMED
ND19XP-016×15 EUDAMED
ND19XP-025×40 EUDAMED
ND18-018×13 EUDAMED
ND18-030×75 EUDAMED
ND19XP-018×30 EUDAMED
ND18-030×30 EUDAMED
ND18-025×30 EUDAMED
ND18-020×15 EUDAMED
ND18-030×40 EUDAMED

Identifiers

Primary DI / UDI-DI
06977427145291 EUDAMED
06977427145123 EUDAMED
06977427145116 EUDAMED
06977427145369 EUDAMED
06977427145208 EUDAMED
06977427145307 EUDAMED
06977427145086 EUDAMED
06977427145185 EUDAMED
06977427145239 EUDAMED
06977427145154 EUDAMED
06977427145130 EUDAMED
06977427145093 EUDAMED
06977427145161 EUDAMED
Basic UDI-DI
697168527ZJZ004WW EUDAMED
697168527ZJZ002WS 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

Non Dolens by Changchun AiK Medical Devices 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Changchun AiK Medical Devices Co., Ltd.
EUDAMED SRN
CN-MF-000026736
Authorised Representative
Llins Service & Consulting GmbH DE-AR-000009077

Sources (13)

  • EUDAMED 6a047c5d-2aec-45c4-a3d0-660f9bab49c1 61 fields · synced Aug 3, 2026
  • EUDAMED 81b59f68-eef4-4134-96c9-cf7639b7c4a6 61 fields · synced May 17, 2026
  • EUDAMED 22e3099b-fcd5-4730-85ff-9d893a3a6ceb 61 fields · synced May 17, 2026
  • EUDAMED 13fa9b88-d291-47d1-809c-3740249466f4 61 fields · synced May 17, 2026
  • EUDAMED 8f649030-8239-4f58-acb8-114b55435a00 61 fields · synced May 17, 2026
  • EUDAMED 6f1bb6c3-3364-4bc9-b756-21e1052fe0d0 61 fields · synced May 17, 2026
  • EUDAMED b0336d72-a82f-48d5-bb03-b13cf3caf7d0 61 fields · synced May 18, 2026
  • EUDAMED 2998f227-9d91-42f3-9f33-56924f150704 61 fields · synced May 18, 2026
  • EUDAMED c04957e1-74ee-42ce-89c5-e468ec452750 61 fields · synced May 18, 2026
  • EUDAMED 038a27eb-6e98-4b6e-9122-bed0fbc4e594 61 fields · synced May 18, 2026
  • EUDAMED 45474a4c-aecf-46b5-852b-1732c6763945 61 fields · synced May 18, 2026
  • EUDAMED 972e5b2c-205c-4bb0-bec5-bc3b6c7d0217 61 fields · synced May 19, 2026
  • EUDAMED 0a5d2e69-04ba-4654-b9c2-4b1703daf6f1 61 fields · synced May 19, 2026