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Accufuser M8EP
EUDAMEDClass 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
Identity
- Device Name
- Accufuser M8EP EUDAMED
- Model / Reference
- ME212410S EUDAMEDME201210S EUDAMEDME212415M EUDAMEDME124815L EUDAMEDME212430S EUDAMEDME201210M EUDAMEDME201260M EUDAMEDME201260S EUDAMEDME224860M EUDAMEDME201215S EUDAMEDME101215S EUDAMEDME112410L EUDAMEDME212415L EUDAMEDME224810XL EUDAMEDME212430L EUDAMEDME112460S EUDAMEDME212430M EUDAMEDME124830M EUDAMEDME124815XL EUDAMEDME124860L EUDAMEDME124830L EUDAMEDME224830L EUDAMEDME224815XL EUDAMEDME224860XL EUDAMEDME124815M EUDAMEDME112430S EUDAMEDME112430L EUDAMEDME224860L EUDAMEDME224810M EUDAMEDME212460L EUDAMEDME124810L EUDAMEDME124860XL EUDAMEDME212410M EUDAMEDME124830XL EUDAMEDME101210M EUDAMEDME101215MEJ EUDAMEDME101215M EUDAMEDME101260S EUDAMEDME101230S EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ME212410SG6 EUDAMEDD-ME201210SEY EUDAMEDD-ME212415MG9 EUDAMEDD-ME124815LHM EUDAMEDD-ME212430SGG EUDAMEDD-ME201210MEL EUDAMEDD-ME201260MFD EUDAMEDD-ME201260SFR EUDAMEDD-ME224860MJJ EUDAMEDD-ME201215SFF EUDAMEDD-ME101215SEW EUDAMEDD-ME112410LF7 EUDAMEDD-ME212415LG7 EUDAMEDD-ME224810XLAN EUDAMEDD-ME212430LG2 EUDAMEDD-ME112460SGE EUDAMEDD-ME212430MG4 EUDAMEDD-ME124830MHJ EUDAMEDD-ME124815XLAU EUDAMEDD-ME124860LHX EUDAMEDD-ME124830LHG EUDAMEDD-ME224830LHZ EUDAMEDD-ME224815XLBF EUDAMEDD-ME224860XLBR EUDAMEDD-ME124815MHP EUDAMEDD-ME112430SFX EUDAMEDD-ME112430LFH EUDAMEDD-ME224860LJG EUDAMEDD-ME224810MHR EUDAMEDD-ME212460LGH EUDAMEDD-ME124810LH6 EUDAMEDD-ME124860XLB6 EUDAMEDD-ME212410MFS EUDAMEDD-ME124830XLAH EUDAMEDD-ME101210ME3 EUDAMEDD-ME101215MEJ EUDAMEDD-ME101260SF8 EUDAMEDD-ME101230SER EUDAMED
- Basic UDI-DI
- B-ME212410SG6 EUDAMEDB-ME201210SEY EUDAMEDB-ME212415MG9 EUDAMEDB-ME124815LHM EUDAMEDB-ME212430SGG EUDAMEDB-ME201210MEL EUDAMEDB-ME201260MFD EUDAMEDB-ME201260SFR EUDAMEDB-ME224860MJJ EUDAMEDB-ME201215SFF EUDAMEDB-ME101215SEW EUDAMEDB-ME112410LF7 EUDAMEDB-ME212415LG7 EUDAMEDB-ME224810XLAN EUDAMEDB-ME212430LG2 EUDAMEDB-ME112460SGE EUDAMEDB-ME212430MG4 EUDAMEDB-ME124830MHJ EUDAMEDB-ME124815XLAU EUDAMEDB-ME124860LHX EUDAMEDB-ME124830LHG EUDAMEDB-ME224830LHZ EUDAMEDB-ME224815XLBF EUDAMEDB-ME224860XLBR EUDAMEDB-ME124815MHP EUDAMEDB-ME112430SFX EUDAMEDB-ME112430LFH EUDAMEDB-ME224860LJG EUDAMEDB-ME224810MHR EUDAMEDB-ME212460LGH EUDAMEDB-ME124810LH6 EUDAMEDB-ME124860XLB6 EUDAMEDB-ME212410MFS EUDAMEDB-ME124830XLAH EUDAMEDB-ME101210ME3 EUDAMEDB-ME101215MEJ EUDAMEDB-ME101260SF8 EUDAMEDB-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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-ME212410SG6 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Woo Young Medical Co., Ltd.
- 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