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Accufuser M8EP

EUDAMED

Class IIb (EU MDR)

Ref ME212410SRef ME201210SRef ME212415MRef ME124815LRef ME212430SRef ME201210MRef ME201260MRef ME201260SRef ME224860MRef ME201215SRef ME101215SRef ME112410LRef ME212415LRef ME224810XLRef ME212430LRef ME112460SRef ME212430MRef ME124830MRef ME124815XLRef ME124860LRef ME124830LRef ME224830LRef ME224815XLRef ME224860XLRef ME124815MRef ME112430SRef ME112430LRef ME224860LRef ME224810MRef ME212460LRef ME124810LRef ME124860XLRef ME212410MRef ME124830XLRef ME101210MRef ME101215MModel ME101215MEJRef ME101260SRef ME101230S

by Woo Young Medical Co., Ltd.

Identity

Device Name
Accufuser M8EP EUDAMED
Model / Reference
ME212410S EUDAMED
ME201210S EUDAMED
ME212415M EUDAMED
ME124815L EUDAMED
ME212430S EUDAMED
ME201210M EUDAMED
ME201260M EUDAMED
ME201260S EUDAMED
ME224860M EUDAMED
ME201215S EUDAMED
ME101215S EUDAMED
ME112410L EUDAMED
ME212415L EUDAMED
ME224810XL EUDAMED
ME212430L EUDAMED
ME112460S EUDAMED
ME212430M EUDAMED
ME124830M EUDAMED
ME124815XL EUDAMED
ME124860L EUDAMED
ME124830L EUDAMED
ME224830L EUDAMED
ME224815XL EUDAMED
ME224860XL EUDAMED
ME124815M EUDAMED
ME112430S EUDAMED
ME112430L EUDAMED
ME224860L EUDAMED
ME224810M EUDAMED
ME212460L EUDAMED
ME124810L EUDAMED
ME124860XL EUDAMED
ME212410M EUDAMED
ME124830XL EUDAMED
ME101210M EUDAMED
ME101215MEJ EUDAMED
ME101215M EUDAMED
ME101260S EUDAMED
ME101230S EUDAMED

Identifiers

Primary DI / UDI-DI
D-ME212410SG6 EUDAMED
D-ME201210SEY EUDAMED
D-ME212415MG9 EUDAMED
D-ME124815LHM EUDAMED
D-ME212430SGG EUDAMED
D-ME201210MEL EUDAMED
D-ME201260MFD EUDAMED
D-ME201260SFR EUDAMED
D-ME224860MJJ EUDAMED
D-ME201215SFF EUDAMED
D-ME101215SEW EUDAMED
D-ME112410LF7 EUDAMED
D-ME212415LG7 EUDAMED
D-ME224810XLAN EUDAMED
D-ME212430LG2 EUDAMED
D-ME112460SGE EUDAMED
D-ME212430MG4 EUDAMED
D-ME124830MHJ EUDAMED
D-ME124815XLAU EUDAMED
D-ME124860LHX EUDAMED
D-ME124830LHG EUDAMED
D-ME224830LHZ EUDAMED
D-ME224815XLBF EUDAMED
D-ME224860XLBR EUDAMED
D-ME124815MHP EUDAMED
D-ME112430SFX EUDAMED
D-ME112430LFH EUDAMED
D-ME224860LJG EUDAMED
D-ME224810MHR EUDAMED
D-ME212460LGH EUDAMED
D-ME124810LH6 EUDAMED
D-ME124860XLB6 EUDAMED
D-ME212410MFS EUDAMED
D-ME124830XLAH EUDAMED
D-ME101210ME3 EUDAMED
D-ME101215MEJ EUDAMED
D-ME101260SF8 EUDAMED
D-ME101230SER EUDAMED
Basic UDI-DI
B-ME212410SG6 EUDAMED
B-ME201210SEY EUDAMED
B-ME212415MG9 EUDAMED
B-ME124815LHM EUDAMED
B-ME212430SGG EUDAMED
B-ME201210MEL EUDAMED
B-ME201260MFD EUDAMED
B-ME201260SFR EUDAMED
B-ME224860MJJ EUDAMED
B-ME201215SFF EUDAMED
B-ME101215SEW EUDAMED
B-ME112410LF7 EUDAMED
B-ME212415LG7 EUDAMED
B-ME224810XLAN EUDAMED
B-ME212430LG2 EUDAMED
B-ME112460SGE EUDAMED
B-ME212430MG4 EUDAMED
B-ME124830MHJ EUDAMED
B-ME124815XLAU EUDAMED
B-ME124860LHX EUDAMED
B-ME124830LHG EUDAMED
B-ME224830LHZ EUDAMED
B-ME224815XLBF EUDAMED
B-ME224860XLBR EUDAMED
B-ME124815MHP EUDAMED
B-ME112430SFX EUDAMED
B-ME112430LFH EUDAMED
B-ME224860LJG EUDAMED
B-ME224810MHR EUDAMED
B-ME212460LGH EUDAMED
B-ME124810LH6 EUDAMED
B-ME124860XLB6 EUDAMED
B-ME212410MFS EUDAMED
B-ME124830XLAH EUDAMED
B-ME101210ME3 EUDAMED
B-ME101215MEJ EUDAMED
B-ME101260SF8 EUDAMED
B-ME101230SER EUDAMED
EMDN Code
A05010202 ELASTOMERIC SYSTEMS - VARIABLE FLOW WITH ADDITIONAL BOLUS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Accufuser M8EP by Woo Young Medical Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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

Manufacturer

EUDAMED SRN
KR-MF-000022134
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (38)

  • EUDAMED fbf0f8ac-9948-4bdc-af7c-df420005e696 61 fields · synced Oct 5, 2026
  • EUDAMED 1314a598-587c-4407-a123-13125d94c0f5 61 fields · synced May 11, 2026
  • EUDAMED 4b3ddfe7-d52f-4232-9d0d-f4b568916be1 61 fields · synced May 16, 2026
  • EUDAMED 30b039e9-56ea-4b2b-a49e-baa795ddce39 61 fields · synced May 16, 2026
  • EUDAMED f5a3ad83-d72d-4433-834e-7a4627236395 61 fields · synced May 16, 2026
  • EUDAMED 4f65e3df-e835-4cf1-ab83-f39571bd5e1b 61 fields · synced May 16, 2026
  • EUDAMED f8c54153-41d1-4fb1-827b-830f2b9148e7 61 fields · synced May 16, 2026
  • EUDAMED e73bf222-0291-42fe-a940-3b6e086a37d9 61 fields · synced May 16, 2026
  • EUDAMED f4be544f-cced-40ca-8761-44fb21568c05 61 fields · synced May 16, 2026
  • EUDAMED bd5f895f-9a44-4ca1-a008-0f71ee5e511d 61 fields · synced May 17, 2026
  • EUDAMED 7efe1dc6-003d-4017-8db8-84173492b904 61 fields · synced May 17, 2026
  • EUDAMED ad1c74af-8823-4833-bcc9-68f3cda0ac2b 61 fields · synced May 17, 2026
  • EUDAMED 714d10b6-dbda-43da-843d-a3e39ac61c03 61 fields · synced May 17, 2026
  • EUDAMED 437d74c6-a6c9-4ce2-baac-9a26bc867b6a 61 fields · synced May 17, 2026
  • EUDAMED f7b70af2-063c-48c7-9184-88e34d347115 61 fields · synced May 17, 2026
  • EUDAMED 50446baa-9f63-45a7-a3e9-64beb02ecb04 61 fields · synced May 17, 2026
  • EUDAMED b92dacd3-18ec-4aba-90d5-89b2bc9f238c 61 fields · synced May 17, 2026
  • EUDAMED f3328805-7824-48c4-a9ad-1616d2dd9de9 61 fields · synced May 17, 2026
  • EUDAMED c5e21ff2-7c1a-46d7-b146-e0f7313f907e 61 fields · synced May 17, 2026
  • EUDAMED 4ae3eb74-bf57-4a18-a13e-c87efa1e0af6 61 fields · synced May 18, 2026
  • EUDAMED 7930078b-421a-48f0-b1a3-629e5bbb2466 61 fields · synced May 18, 2026
  • EUDAMED ff956ec2-38be-49df-84a1-8ab709fe1ebd 61 fields · synced May 18, 2026
  • EUDAMED 8de7f9d2-9fca-4959-a425-5f74b3c56a0f 61 fields · synced May 18, 2026
  • EUDAMED f14de3ba-9cd6-409e-9308-640508c60393 61 fields · synced May 18, 2026
  • EUDAMED 4f938837-737c-4e12-aaf3-8cf32053d235 61 fields · synced May 18, 2026
  • EUDAMED 851daa6b-7546-47a1-a40e-d7c7cc7e9836 61 fields · synced May 18, 2026
  • EUDAMED 6c8d38a6-a7bc-47df-9553-e10bb74f3c6a 61 fields · synced May 18, 2026
  • EUDAMED 8e483509-a628-432a-afef-8f16f30e820a 61 fields · synced May 18, 2026
  • EUDAMED 8bc46ee9-b409-4c41-8d4f-da961641b350 61 fields · synced May 18, 2026
  • EUDAMED c1607757-f4e8-4603-aabb-e21bba6b18c1 61 fields · synced May 18, 2026
  • EUDAMED 1eeec64c-476e-4683-b0a2-151e35fd1595 61 fields · synced May 18, 2026
  • EUDAMED fa24100a-b97f-43d8-b61c-6534ecfcecaf 61 fields · synced May 18, 2026
  • EUDAMED 21b6d6ac-4c50-4413-acd3-dce13316f44d 61 fields · synced May 18, 2026
  • EUDAMED 007dd692-b2f5-4eb6-bcad-9033f76e2a13 61 fields · synced May 18, 2026
  • EUDAMED 2b45e34b-ca47-4217-9bb0-b189efb54ff2 61 fields · synced May 19, 2026
  • EUDAMED 8e109dd5-af57-4b29-8f3b-a3c05a738108 61 fields · synced May 19, 2026
  • EUDAMED 8fc24d3a-e737-4e79-ac03-f1e24b5ed583 61 fields · synced May 19, 2026
  • EUDAMED b677e4c8-421c-4ddf-a6e4-d2ad5e0660ad 61 fields · synced May 19, 2026