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Alphacheck

EUDAMED

Class IIa (EU MDR)

Ref HB-085Ref IPN31*8Model IPN-32-4Ref SL-28-16M2Model Type A, Type B, Type C, Type T, Type MRef BL-30G RainbowRef 31*8Ref IPN31*5Ref SL-21-24M2Ref BL-28GRef IPN31*6Ref BL-30GRef HB-100Ref SPN-30-5Ref HB-065Ref ALS-01Ref 31*6Ref SPN-30-8Ref SL-28-16MRef IPN32*4Ref 32*4Ref HB-150

by Promisemed Hangzhou Meditech Co., Ltd.

Identity

Trade Name
Alphacheck EUDAMED
Device Name
Heel Blood Lancet EUDAMED
Insulin Pen Needles EUDAMED
Safety Blood Lancets EUDAMED
Blood Lancets EUDAMED
safety pen needle EUDAMED
Alcohol Swabs EUDAMED
Model / Reference
HB-085 EUDAMED
IPN-32-4 EUDAMED
IPN31*8 EUDAMED
Type A, Type B, Type C, Type T, Type M EUDAMED
SL-28-16M2 EUDAMED
BL-30G Rainbow EUDAMED
31*8 EUDAMED
IPN31*5 EUDAMED
SL-21-24M2 EUDAMED
BL-28G EUDAMED
IPN31*6 EUDAMED
BL-30G EUDAMED
HB-100 EUDAMED
SPN-30-5 EUDAMED
HB-065 EUDAMED
ALS-01 EUDAMED
31*6 EUDAMED
SPN-30-8 EUDAMED
SL-28-16M EUDAMED
IPN32*4 EUDAMED
32*4 EUDAMED
HB-150 EUDAMED

Identifiers

Primary DI / UDI-DI
06971227402448 EUDAMED
06978111920392 EUDAMED
06971227402578 EUDAMED
06971227409737 EUDAMED
06971227402141 EUDAMED
06971227402172 EUDAMED
06971227403698 EUDAMED
06975965295881 EUDAMED
06971227403711 EUDAMED
06971227401946 EUDAMED
06971227402561 EUDAMED
06971227401922 EUDAMED
06978111920408 EUDAMED
06971227402110 EUDAMED
06971227402431 EUDAMED
06978111920279 EUDAMED
06971227401960 EUDAMED
06971227402127 EUDAMED
06971227403834 EUDAMED
06971227403681 EUDAMED
06971227403704 EUDAMED
06971227402233 EUDAMED
06978111920385 EUDAMED
06978111920415 EUDAMED
06971227401939 EUDAMED
06971227401953 EUDAMED
06971227402134 EUDAMED
Basic UDI-DI
697122740HBX7 EUDAMED
697122740IPNPZ EUDAMED
697122740SLYU EUDAMED
697122740BLX9 EUDAMED
697122740SPNRK EUDAMED
697122740ALSNP EUDAMED
Unit of Use DI
86971227402444 EUDAMED
86978111920398 EUDAMED
86971227402574 EUDAMED
86971227409733 EUDAMED
86971227402147 EUDAMED
86971227402178 EUDAMED
86971227403694 EUDAMED
86975965295887 EUDAMED
86971227403717 EUDAMED
86971227401942 EUDAMED
86971227402567 EUDAMED
86971227401928 EUDAMED
86978111920404 EUDAMED
86971227402116 EUDAMED
86971227402437 EUDAMED
86978111920275 EUDAMED
86971227401966 EUDAMED
86971227402123 EUDAMED
86971227403830 EUDAMED
86971227403687 EUDAMED
86971227403700 EUDAMED
86971227402239 EUDAMED
86978111920381 EUDAMED
86978111920411 EUDAMED
86971227401935 EUDAMED
86971227401959 EUDAMED
86971227402130 EUDAMED
EMDN Code
V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
V010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
M0202030102 NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class I EUDAMED
Market of Registration
Greece EUDAMED
Sweden EUDAMED
Germany EUDAMED
Austria 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

EUDAMEDEUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Blood lancet, single-use

Alphacheck by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Blood lancet, single-use.

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 (27)

  • EUDAMED 67986f2a-a98a-445c-ac37-ce97efa2a3e7 61 fields · synced Sep 18, 2026
  • EUDAMED feafe75b-1e7f-41f4-98fa-48ce9386a083 61 fields · synced May 16, 2026
  • EUDAMED 5c01423b-c074-4cd3-a703-d83b777f9637 61 fields · synced May 16, 2026
  • EUDAMED 961f3084-acb8-4fbc-bd81-780a6e30bddf 61 fields · synced May 16, 2026
  • EUDAMED ba71d1c5-75a5-466e-b95e-58e58438cf54 61 fields · synced May 16, 2026
  • EUDAMED 1e070cd6-08e6-473c-b922-70ccd6bbe6e3 61 fields · synced May 17, 2026
  • EUDAMED 036c6d05-1884-480a-a233-6cfba24a472e 61 fields · synced May 17, 2026
  • EUDAMED 32f0254d-1b43-418b-aa96-c7c6fac4e85d 61 fields · synced May 17, 2026
  • EUDAMED 90dcc8e2-5670-4f76-91cf-a1998ddfcbc3 61 fields · synced May 17, 2026
  • EUDAMED 821ee09c-bab7-402f-9b93-52a1a52236be 61 fields · synced May 17, 2026
  • EUDAMED ce2d32e6-d01b-47e1-a777-128819eed781 61 fields · synced May 17, 2026
  • EUDAMED b7203bc2-2a55-4842-b9d7-87cb1012a1f7 61 fields · synced May 17, 2026
  • EUDAMED 85340242-9304-4fe4-b283-5a22f4fec8ec 61 fields · synced May 17, 2026
  • EUDAMED 59225e5d-1422-4c51-af60-7452de1dca56 61 fields · synced May 17, 2026
  • EUDAMED b4a0ff99-c9ab-4312-9671-b2d61617edf0 61 fields · synced May 18, 2026
  • EUDAMED a50f6720-be04-4027-82e0-5b2aa02c257f 61 fields · synced May 18, 2026
  • EUDAMED d0f87570-0b36-4328-8436-8467904b4926 61 fields · synced May 18, 2026
  • EUDAMED 29f51ca0-27e0-4268-991d-ea918747ed03 61 fields · synced May 18, 2026
  • EUDAMED d564d044-425e-450f-922e-14c7c2f20f44 61 fields · synced May 18, 2026
  • EUDAMED 65917b32-4993-40ae-b8e8-9278028ee221 61 fields · synced May 18, 2026
  • EUDAMED a5c26d59-ae4a-4751-912d-aff67f33bb8c 61 fields · synced May 18, 2026
  • EUDAMED 50d569e0-a820-46c8-a4ad-c6f0926da850 61 fields · synced May 19, 2026
  • EUDAMED 157c5a17-8447-4327-8f77-2e1136e78826 61 fields · synced May 19, 2026
  • EUDAMED 0cd6b0cc-227f-4545-818c-077e5eca558b 61 fields · synced May 19, 2026
  • EUDAMED b9d554a2-3573-46fe-bec6-9680f6238607 61 fields · synced May 19, 2026
  • EUDAMED 78d1ef88-9a2c-49ed-a1bc-c74b13d0e594 61 fields · synced May 19, 2026
  • EUDAMED ab9181fd-21c4-40a2-a8ad-eaaace2770b2 61 fields · synced May 19, 2026