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SoftFine

EUDAMED

Class IIa (EU MDR)

Ref IPN-31-6 Model IPN-32-4Ref IPN-31-5Ref IPN-31-8

by Promisemed Hangzhou Meditech Co., Ltd.

Identity

Trade Name
SoftFine EUDAMED
Device Name
Insulin Pen Needles EUDAMED
Model / Reference
IPN-32-4 EUDAMED
IPN-31-6 EUDAMED
IPN-31-5 EUDAMED
IPN-31-8 EUDAMED

Identifiers

Primary DI / UDI-DI
06971227406880 EUDAMED
06971227406873 EUDAMED
06971227406903 EUDAMED
06971227406897 EUDAMED
Basic UDI-DI
697122740IPNPZ EUDAMED
Unit of Use DI
86971227406886 EUDAMED
86971227406879 EUDAMED
86971227406909 EUDAMED
86971227406893 EUDAMED
EMDN Code
A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Sweden 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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

SoftFine by Promisemed Hangzhou Meditech 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

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Manufacturer

Manufacturer
Promisemed Hangzhou Meditech Co., Ltd.
EUDAMED SRN
CN-MF-000008465
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (4)

  • EUDAMED 82c4329a-d604-47b8-b625-a9a17a5b54e1 61 fields · synced Oct 6, 2026
  • EUDAMED 86d82338-cc33-43cd-916d-d80eb11b1971 61 fields · synced May 18, 2026
  • EUDAMED 80c6b55b-0a93-453f-926b-2f1a9bdb213e 61 fields · synced May 18, 2026
  • EUDAMED 0e1854fd-7309-4593-ad34-373a7ef25442 61 fields · synced May 18, 2026