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4sure

EUDAMED

Class IIa (EU MDR)

Ref IPN31*5Model IPN-32-4Ref IPN32*6Ref SL-23-18TModel Type A, Type B, Type C, Type T, Type MRef IPN32*4Ref IPN31*8Ref SL-28-16TRef IPN31*6Ref IPN31*4

by Promisemed Hangzhou Meditech Co., Ltd.

Identity

Trade Name
4SURE EUDAMED
Device Name
Insulin Pen Needles EUDAMED
Safety Blood Lancets EUDAMED
Model / Reference
IPN-32-4 EUDAMED
IPN31*5 EUDAMED
IPN32*6 EUDAMED
Type A, Type B, Type C, Type T, Type M EUDAMED
SL-23-18T EUDAMED
IPN32*4 EUDAMED
IPN31*8 EUDAMED
SL-28-16T EUDAMED
IPN31*6 EUDAMED
IPN31*4 EUDAMED

Identifiers

Primary DI / UDI-DI
06971227404374 EUDAMED
06971227404442 EUDAMED
06971227404466 EUDAMED
06971227409171 EUDAMED
06971227404428 EUDAMED
06971227404176 EUDAMED
06971227404480 EUDAMED
06971227406194 EUDAMED
06971227404473 EUDAMED
06971227404459 EUDAMED
06971227406200 EUDAMED
06971227404398 EUDAMED
Basic UDI-DI
697122740IPNPZ EUDAMED
697122740SLYU EUDAMED
Unit of Use DI
86971227404370 EUDAMED
86971227404448 EUDAMED
86971227404462 EUDAMED
86971227409177 EUDAMED
86971227404424 EUDAMED
86971227404172 EUDAMED
86971227404486 EUDAMED
86971227406190 EUDAMED
86971227404479 EUDAMED
86971227404455 EUDAMED
86971227406206 EUDAMED
86971227404394 EUDAMED
EMDN Code
A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE 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

EUDAMEDEUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

4sure 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 (12)

  • EUDAMED 75dfbd05-65e8-489b-8a84-35387bd1187c 61 fields · synced Oct 5, 2026
  • EUDAMED cfed3f25-1275-4751-bcb0-c206b323d56a 61 fields · synced May 17, 2026
  • EUDAMED 986d9fc9-58a2-4318-b8b8-4f7527448574 61 fields · synced May 17, 2026
  • EUDAMED 377ddde7-bca7-4524-a774-3c1d3f3d830b 61 fields · synced May 17, 2026
  • EUDAMED 5fff7554-3c7a-4476-9340-95d5b80e126c 61 fields · synced May 17, 2026
  • EUDAMED b7b1f4c6-cc42-4c2f-a05c-13afa10ccb8d 61 fields · synced May 17, 2026
  • EUDAMED e5e64d60-3385-4fe5-b7c3-6f02015cbe5b 61 fields · synced May 18, 2026
  • EUDAMED 317d133e-414a-426a-af26-4c728e71ce1f 61 fields · synced May 19, 2026
  • EUDAMED e6b258ff-1f3b-4f83-ba21-919b2151c901 61 fields · synced May 19, 2026
  • EUDAMED 7bea479a-0164-448b-9f15-1f379a73ffbd 61 fields · synced May 19, 2026
  • EUDAMED 12a2edce-ec47-45e3-9918-8cacdd4a6756 61 fields · synced May 19, 2026
  • EUDAMED eb4fd0d1-636d-43a1-a9b6-a95e3918d369 61 fields · synced May 19, 2026