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Blood Sampler

EUDAMED

Class IIa (EU MDR)

Ref isafeP-1Ref isafeA-1Ref isafeA-1-WARef isafeA-1NRef isafeC-115BYRef isafeP-3NRef isafeA-1-C4ARef isafeC-100BNRef isafeA-3Ref isafeA-3-C2ARef isafeA-3-C5ARef isafeC-100AYRef isafeP-1-WBRef isafeP-3-WBRef isafeP-1-WARef isafeA-1-C2ARef isafeC-85ANRef isafeP-1-C1ARef isafeP-3-C3ARef isafeP-3-WARef isafeP-1NRef isafeA-3NRef isafeP-3-S2BRef isafeP-3-C5ARef isafeP-1-S1BRef isafeP-3-C2ARef isafeP-1-C2ARef isafeA-1-C1ARef isafeA-3-WARef isafeP-1-C4A

by Edan Instruments, Inc.

Identity

Trade Name
Blood Sampler EUDAMED
Device Name
Blood Sampler EUDAMED
Model / Reference
isafeP-1 EUDAMED
isafeA-1 EUDAMED
isafeA-1-WA EUDAMED
isafeA-1N EUDAMED
isafeC-115BY EUDAMED
isafeP-3N EUDAMED
isafeA-1-C4A EUDAMED
isafeC-100BN EUDAMED
isafeA-3 EUDAMED
isafeA-3-C2A EUDAMED
isafeA-3-C5A EUDAMED
isafeC-100AY EUDAMED
isafeP-1-WB EUDAMED
isafeP-3-WB EUDAMED
isafeP-1-WA EUDAMED
isafeA-1-C2A EUDAMED
isafeC-85AN EUDAMED
isafeP-1-C1A EUDAMED
isafeP-3-C3A EUDAMED
isafeP-3-WA EUDAMED
isafeP-1N EUDAMED
isafeA-3N EUDAMED
isafeP-3-S2B EUDAMED
isafeP-3-C5A EUDAMED
isafeP-1-S1B EUDAMED
isafeP-3-C2A EUDAMED
isafeP-1-C2A EUDAMED
isafeA-1-C1A EUDAMED
isafeA-3-WA EUDAMED
isafeP-1-C4A EUDAMED

Identifiers

Primary DI / UDI-DI
06944413837867 EUDAMED
06944413825949 EUDAMED
06944413855823 EUDAMED
06944413837805 EUDAMED
06944413834750 EUDAMED
06944413837812 EUDAMED
06944413856226 EUDAMED
06944413855328 EUDAMED
06944413855908 EUDAMED
06944413826069 EUDAMED
06944413825963 EUDAMED
06944413856110 EUDAMED
06944413856127 EUDAMED
06944413834743 EUDAMED
06944413856264 EUDAMED
06944413825994 EUDAMED
06944413856073 EUDAMED
06944413856240 EUDAMED
06944413855892 EUDAMED
06944413826007 EUDAMED
06944413826120 EUDAMED
06944413855939 EUDAMED
06944413856189 EUDAMED
06944413825932 EUDAMED
06944413856059 EUDAMED
06944413837935 EUDAMED
06944413856332 EUDAMED
06944413855274 EUDAMED
06944413837843 EUDAMED
06944413856295 EUDAMED
06944413856219 EUDAMED
06944413856400 EUDAMED
06944413826137 EUDAMED
06944413855960 EUDAMED
06944413856066 EUDAMED
06944413856394 EUDAMED
06944413856011 EUDAMED
06944413855847 EUDAMED
06944413856141 EUDAMED
06944413837959 EUDAMED
06944413856318 EUDAMED
06944413856288 EUDAMED
06944413855946 EUDAMED
06944413855830 EUDAMED
06944413855885 EUDAMED
06944413856356 EUDAMED
06944413855991 EUDAMED
06944413855311 EUDAMED
06944413826021 EUDAMED
06944413826052 EUDAMED
06944413856042 EUDAMED
Basic UDI-DI
69444138isafePSBW EUDAMED
69444138isafeAsC7 EUDAMED
69444138isafeAPWSUV EUDAMED
69444138isafeCsCD EUDAMED
EMDN Code
A02010502 BLOOD GAS ANALYSIS, SYRINGES WITH SAFETY NEEDLE AND KITS EUDAMED
W0501010103 BLOOD GAS SAMPLES COLLECTION, SYRINGES WITHOUT NEEDLE EUDAMED
W0501010203 BLOOD COLLECTION, CAPILLARY TUBES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class A EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMEDEUDAMED

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

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Blood Sampler by Edan Instruments, Inc. — Class IIa — IVDR, MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Edan Instruments, Inc.
EUDAMED SRN
CN-MF-000009957
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (51)

  • EUDAMED 5306599e-a852-4e76-acaf-bf3db9a3471f 61 fields · synced Sep 30, 2026
  • EUDAMED 9fb98dcd-60a1-4693-81eb-fcac18982493 61 fields · synced May 17, 2026
  • EUDAMED 79ba6b03-8a25-4180-9ef6-5f3b471408a0 61 fields · synced May 19, 2026
  • EUDAMED 01243e48-d7a4-4759-8a4a-8ea63b0a2436 61 fields · synced Jun 14, 2026
  • EUDAMED 6464b1e3-6685-4949-8e65-ee69e754e48f 61 fields · synced Jun 14, 2026
  • EUDAMED e558a171-073f-4121-b1e0-c27293640366 61 fields · synced Jun 18, 2026
  • EUDAMED 8492d6e5-ab6c-468b-a940-92ee185e12bc 61 fields · synced Jun 20, 2026
  • EUDAMED 364996e6-038f-400c-9b92-ceb77009224f 61 fields · synced Jun 20, 2026
  • EUDAMED db94f9b7-a152-48d9-ab55-5796e8ae6a57 61 fields · synced Jun 20, 2026
  • EUDAMED e788a77a-d546-454e-bc50-875e0674fa9d 61 fields · synced Jul 8, 2026
  • EUDAMED d7bfd73b-f25a-43a1-8c48-ac3c94e2d1ab 61 fields · synced Jul 9, 2026
  • EUDAMED f2849f75-2819-4eff-a4e8-79a2b4096cc4 61 fields · synced Jul 9, 2026
  • EUDAMED e159501a-9a7c-434f-b02a-d55196fa75b0 61 fields · synced Jul 9, 2026
  • EUDAMED df5978af-5801-41a4-8918-1682b9f28573 61 fields · synced Jul 9, 2026
  • EUDAMED c059bfc3-e658-46e6-9edf-e3b8361f25fe 61 fields · synced Jul 9, 2026
  • EUDAMED 8b45337d-65c9-490d-a917-404d65191a23 61 fields · synced Jul 9, 2026
  • EUDAMED 2fbcba4d-c23a-4dc0-b0be-fad949fb000f 61 fields · synced Jul 9, 2026
  • EUDAMED 9e3edf25-23b1-4a5a-a2cb-cb8f41d4099e 61 fields · synced Jul 10, 2026
  • EUDAMED 6eadff3f-ecaf-4955-96de-e410e0929b96 61 fields · synced Jul 10, 2026
  • EUDAMED 3ca2ff94-1b0c-4ec8-ae09-8a707d40214f 61 fields · synced Jul 11, 2026
  • EUDAMED c17ef458-54f5-4ffb-b7d6-758e7ecccae7 61 fields · synced Jul 11, 2026
  • EUDAMED 93e226ed-6f2d-481f-a0d6-fc1ec55fbe9f 61 fields · synced Jul 11, 2026
  • EUDAMED a83f8119-f897-4ad7-a218-fd1c73b2ab73 61 fields · synced Jul 11, 2026
  • EUDAMED fa149919-d0e9-484c-8b46-4ccb59b484a4 61 fields · synced Jul 11, 2026
  • EUDAMED 64330f24-f905-4c72-8579-4157957a7188 61 fields · synced Jul 13, 2026
  • EUDAMED ded5c204-d5a3-4229-aafb-435e398fde19 61 fields · synced Jul 14, 2026
  • EUDAMED ba5199b1-5774-4f94-a85d-c43327acdc11 61 fields · synced Jul 14, 2026
  • EUDAMED 2c0c8875-3d2c-48d5-a52e-3dd145816555 61 fields · synced Jul 14, 2026
  • EUDAMED d86f105c-1228-49b1-9230-34b72941f9f9 61 fields · synced Jul 16, 2026
  • EUDAMED f1c997a0-d8b8-48f7-90f1-05d840885157 61 fields · synced Jul 17, 2026
  • EUDAMED b64b67dc-fabf-4116-b1b6-6d8830ff58b6 61 fields · synced Jul 18, 2026
  • EUDAMED 83731f06-0381-48b1-902b-3e78d5707d79 61 fields · synced Jul 19, 2026
  • EUDAMED be69c1bc-7561-4794-81a4-079a90735b97 61 fields · synced Jul 19, 2026
  • EUDAMED 570697b8-64dd-4c22-abb1-0d66dfcfb155 61 fields · synced Jul 19, 2026
  • EUDAMED 5e648b80-f7e5-4915-a448-ff8d5fba1144 61 fields · synced Jul 19, 2026
  • EUDAMED 88e142ff-41bc-41b2-8a5a-6a983c06ce59 61 fields · synced Jul 21, 2026
  • EUDAMED 2fe581ce-67ce-49dc-beeb-7843f2b58e79 61 fields · synced Jul 22, 2026
  • EUDAMED 8a02562d-94fc-49c1-84ce-db2a9c578ab8 61 fields · synced Jul 22, 2026
  • EUDAMED 8dc668ce-dc64-498a-aa4b-1e912bbb9b2c 61 fields · synced Jul 24, 2026
  • EUDAMED 8ab3d13e-e143-4438-8981-736b206f7ebb 61 fields · synced Jul 25, 2026
  • EUDAMED 843f9ee2-105e-49b0-a2bd-a0c20d5a7349 61 fields · synced Jul 26, 2026
  • EUDAMED 6fa628ba-131d-462b-9f36-3b53941ae594 61 fields · synced Jul 26, 2026
  • EUDAMED fe7884b6-14fa-43f8-8150-655ac26ae499 61 fields · synced Jul 27, 2026
  • EUDAMED eff1b755-305c-42ec-b8b1-cddf3929d26d 61 fields · synced Jul 31, 2026
  • EUDAMED 7086be67-c22e-4944-87a3-65e6ddb6e69d 61 fields · synced Aug 3, 2026
  • EUDAMED 6279dccf-13af-46da-9524-5bbec284cdb2 61 fields · synced Aug 3, 2026
  • EUDAMED 36cd1263-c7e3-497b-b7cf-78f4730a933b 61 fields · synced Aug 4, 2026
  • EUDAMED d91da07d-938d-4b2e-8780-59504dfc233f 61 fields · synced Aug 4, 2026
  • EUDAMED 44f4a657-e662-4cc4-ba4f-43265795d89b 61 fields · synced Sep 17, 2026
  • EUDAMED 47277efd-ca1c-4d92-9069-c8870ca0c988 61 fields · synced Sep 17, 2026
  • EUDAMED 4075a8c1-5d95-4da6-9d4f-479ea37c429d 61 fields · synced Sep 17, 2026