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Flow Cytometer

EUDAMED

Class A (EU MDR)

Ref C.LS.A5101EModel Cytosteller DX08Ref LongCyte C3080Ref LongCyte C3140Ref LongCyte C2080Ref LongCyte C3111Ref LongCyte C3110Ref LongCyte C3131Ref LongCyte C2041Ref LongCyte C2110Ref LongCyte C3132Ref C.LS.A5002EModel CytoStellar AX01Ref LongCyte C1040Ref LongCyte C3090Ref LongCyte C2040Ref C.LS.A5004EModel CytoStellar AX03Ref LongCyte C2060Ref C.LS.A5107EModel Cytosteller DX06Ref LongCyte C2090Ref C.LS.A5108EModel Cytosteller DX07Ref C.LS.A5105EModel Cytosteller DX04Ref LongCyte C3133Ref C.LS.A5106EModel Cytosteller DX05Ref C.LS.A5003EModel CytoStellar AX02Ref C.LS.A2000L2Ref C.LS.A2000F2Ref C.LS.A2000X2Ref C.LS.A2000E2Ref C.LS.A2000Z4Ref C.LS.A2000Q3Ref C.LS.A2000P2Ref C.LS.A2000G2Ref C.LS.A2000A3Ref C.LS.A2000W2Ref C.LS.A2000S2Ref C.LS.A2000K2Ref C.LS.A2000O3Ref C.LS.A2000B2Ref C.LS.A2000I3Ref C.LS.A2000N2

by Beijing Challen Biotechnology Co., Ltd.

Identity

Trade Name
Flow Cytometer EUDAMED
Device Name
Flow Cytometer EUDAMED
Model / Reference
Cytosteller DX08 EUDAMED
C.LS.A5101E EUDAMED
LongCyte C3080 EUDAMED
LongCyte C3140 EUDAMED
LongCyte C2080 EUDAMED
LongCyte C3111 EUDAMED
LongCyte C3110 EUDAMED
LongCyte C3131 EUDAMED
LongCyte C2041 EUDAMED
LongCyte C2110 EUDAMED
LongCyte C3132 EUDAMED
CytoStellar AX01 EUDAMED
C.LS.A5002E EUDAMED
LongCyte C1040 EUDAMED
LongCyte C3090 EUDAMED
LongCyte C2040 EUDAMED
CytoStellar AX03 EUDAMED
C.LS.A5004E EUDAMED
LongCyte C2060 EUDAMED
Cytosteller DX06 EUDAMED
C.LS.A5107E EUDAMED
LongCyte C2090 EUDAMED
Cytosteller DX07 EUDAMED
C.LS.A5108E EUDAMED
Cytosteller DX04 EUDAMED
C.LS.A5105E EUDAMED
LongCyte C3133 EUDAMED
Cytosteller DX05 EUDAMED
C.LS.A5106E EUDAMED
CytoStellar AX02 EUDAMED
C.LS.A5003E EUDAMED
C.LS.A2000L2 EUDAMED
C.LS.A2000F2 EUDAMED
C.LS.A2000X2 EUDAMED
C.LS.A2000E2 EUDAMED
C.LS.A2000Z4 EUDAMED
C.LS.A2000Q3 EUDAMED
C.LS.A2000P2 EUDAMED
C.LS.A2000G2 EUDAMED
C.LS.A2000A3 EUDAMED
C.LS.A2000W2 EUDAMED
C.LS.A2000S2 EUDAMED
C.LS.A2000K2 EUDAMED
C.LS.A2000O3 EUDAMED
C.LS.A2000B2 EUDAMED
C.LS.A2000I3 EUDAMED
C.LS.A2000N2 EUDAMED

Identifiers

Primary DI / UDI-DI
06975309200380 EUDAMED
06975309200151 EUDAMED
06975309200267 EUDAMED
06975309200090 EUDAMED
06975309200205 EUDAMED
06975309200199 EUDAMED
06975309200236 EUDAMED
06975309200045 EUDAMED
06975309200144 EUDAMED
06975309200243 EUDAMED
06975309200281 EUDAMED
06975309200014 EUDAMED
06975309200168 EUDAMED
06975309200038 EUDAMED
06975309200304 EUDAMED
06975309200076 EUDAMED
06975309200366 EUDAMED
06975309200120 EUDAMED
06975309200373 EUDAMED
06975309200342 EUDAMED
06975309200250 EUDAMED
06975309200359 EUDAMED
06975309200298 EUDAMED
06975309200571 EUDAMED
06975309200519 EUDAMED
06975309200700 EUDAMED
06975309200502 EUDAMED
06975309200724 EUDAMED
06975309200632 EUDAMED
06975309200625 EUDAMED
06975309200526 EUDAMED
06975309200465 EUDAMED
06975309200694 EUDAMED
06975309200656 EUDAMED
06975309200564 EUDAMED
06975309200618 EUDAMED
06975309200472 EUDAMED
06975309200540 EUDAMED
06975309200601 EUDAMED
Basic UDI-DI
697530920038JU EUDAMED
697530920026JM EUDAMED
697530920028JR EUDAMED
697530920030JC EUDAMED
697530920036JQ EUDAMED
697530920037JS EUDAMED
697530920034JL EUDAMED
697530920035JN EUDAMED
697530920029JT EUDAMED
697530920G521E4 EUDAMED
Direct Marketing DI
06975309200380 EUDAMED
06975309200151 EUDAMED
06975309200267 EUDAMED
06975309200090 EUDAMED
06975309200205 EUDAMED
06975309200199 EUDAMED
06975309200236 EUDAMED
06975309200045 EUDAMED
06975309200144 EUDAMED
06975309200243 EUDAMED
06975309200281 EUDAMED
06975309200014 EUDAMED
06975309200168 EUDAMED
06975309200038 EUDAMED
06975309200304 EUDAMED
06975309200076 EUDAMED
06975309200366 EUDAMED
06975309200120 EUDAMED
06975309200373 EUDAMED
06975309200342 EUDAMED
06975309200250 EUDAMED
06975309200359 EUDAMED
06975309200298 EUDAMED
06975309200571 EUDAMED
06975309200519 EUDAMED
06975309200700 EUDAMED
06975309200502 EUDAMED
06975309200724 EUDAMED
06975309200632 EUDAMED
06975309200625 EUDAMED
06975309200526 EUDAMED
06975309200465 EUDAMED
06975309200694 EUDAMED
06975309200656 EUDAMED
06975309200564 EUDAMED
06975309200618 EUDAMED
06975309200472 EUDAMED
06975309200540 EUDAMED
06975309200601 EUDAMED
EMDN Code
W0202040103 CYTOFLOWMETERS - HIGH ROUTINE EUDAMED

Classification

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

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

New Device

No

EUDAMED

Flow Cytometer by Beijing Challen Biotechnology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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

Manufacturer

Manufacturer
Beijing Challen Biotechnology Co., Ltd.
EUDAMED SRN
CN-MF-000023656
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (39)

  • EUDAMED 1a2810ef-7cf6-44ba-afd6-8fa1711c067d 61 fields · synced Sep 18, 2026
  • EUDAMED 32bc3a55-c643-4cc4-aecc-ef03b59bc707 61 fields · synced May 16, 2026
  • EUDAMED 4c94ab68-93c6-4ffd-948a-fc5098681a0d 61 fields · synced May 17, 2026
  • EUDAMED d75acb33-a1ca-4eaf-a911-9280ce7f965d 61 fields · synced May 17, 2026
  • EUDAMED 275b4df9-70bc-4697-b590-c2c1e81f9bb3 61 fields · synced May 17, 2026
  • EUDAMED 00b5d146-a0ba-4617-b401-0a7d7dff382a 61 fields · synced May 17, 2026
  • EUDAMED 973c5466-95f4-4955-9a48-5591e986b295 61 fields · synced May 17, 2026
  • EUDAMED 5037debc-6107-4290-8d72-8e08fcf17f14 61 fields · synced May 17, 2026
  • EUDAMED ae4bc29b-04a0-4879-b2e1-7da8a0a4076b 61 fields · synced May 17, 2026
  • EUDAMED 74e5fb98-5d95-47c4-b0cf-3630cc1f9baf 61 fields · synced May 17, 2026
  • EUDAMED 84794cd8-79d4-458f-ab81-dbd22aa151cf 61 fields · synced May 18, 2026
  • EUDAMED 42bf4449-a43e-42d8-9ee0-e832e33b7b96 61 fields · synced May 18, 2026
  • EUDAMED dda819f5-37c4-4d8a-b8d2-9f4348a0b0d2 61 fields · synced May 18, 2026
  • EUDAMED 6cc02205-69f8-4650-838e-b3fa637b743e 61 fields · synced May 18, 2026
  • EUDAMED dc8020b6-7a7f-4881-8f15-2871ad4f1526 61 fields · synced May 18, 2026
  • EUDAMED 52367f6a-88c4-4c21-82cb-b72164e980b3 61 fields · synced May 18, 2026
  • EUDAMED 52a18d70-0622-4b88-96f4-feaacd46c7a3 61 fields · synced May 18, 2026
  • EUDAMED 9aad3369-b0a6-46e3-be1a-edef98914ec1 61 fields · synced May 18, 2026
  • EUDAMED d73b1628-5e0f-49c7-b8ba-d603f58dd202 61 fields · synced May 18, 2026
  • EUDAMED 5ccbb60e-7993-4a36-8fda-17a0c1f19080 61 fields · synced May 18, 2026
  • EUDAMED adbab812-3076-426b-93c4-a67e5bc71e12 61 fields · synced May 19, 2026
  • EUDAMED 949f6bce-1f98-4883-889f-0ccd40f80008 61 fields · synced May 19, 2026
  • EUDAMED 9eaa9a26-52bd-43f9-946c-892a469e7fd0 61 fields · synced May 19, 2026
  • EUDAMED c87948c3-d181-452e-9fd8-92d49c439234 61 fields · synced Jun 18, 2026
  • EUDAMED 227ab640-ba5f-48aa-850e-00f9e7d90606 61 fields · synced Jul 9, 2026
  • EUDAMED 52260b94-f355-4cd8-b20d-06618a761846 61 fields · synced Jul 11, 2026
  • EUDAMED 3f3d9ab8-5558-4851-a9a4-a0ca41bd6e36 61 fields · synced Jul 12, 2026
  • EUDAMED 6323017b-9d3d-48ff-aec2-b35a109557c3 61 fields · synced Jul 14, 2026
  • EUDAMED 8b2a34d5-f89f-4338-843f-673347ac12c0 61 fields · synced Jul 15, 2026
  • EUDAMED 0b790ead-9f5b-44be-83a3-0002a9931e49 61 fields · synced Jul 15, 2026
  • EUDAMED 19ef090d-bb0d-4fd3-b92f-22e568dfe8d4 61 fields · synced Jul 16, 2026
  • EUDAMED d20e535f-5f55-465f-b86d-5d5099e5c1e7 61 fields · synced Jul 19, 2026
  • EUDAMED f63e468a-fc95-4abb-ad00-8fe34bcc26d1 61 fields · synced Jul 19, 2026
  • EUDAMED d3e8dc9b-c810-4180-8104-28ebce3ae0d4 61 fields · synced Jul 20, 2026
  • EUDAMED 25af3da9-22a6-441e-be43-19b2905ce55c 61 fields · synced Jul 22, 2026
  • EUDAMED 304d6646-b564-4a0f-ae90-bb1cc194f8a6 61 fields · synced Jul 25, 2026
  • EUDAMED 50066f55-772b-49ba-8478-faff55d01f9f 61 fields · synced Jul 26, 2026
  • EUDAMED 4f5a302c-26dd-4c01-b2b4-bb70a3d7573d 61 fields · synced Aug 3, 2026
  • EUDAMED 56121578-05d6-4065-bec3-861013d610b3 61 fields · synced Aug 4, 2026