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Daiwha Corp., Ltd.
EUDAMEDClass IIb (EU MDR)
Ref DW-MTSModel DI-6000VModel DT-150SModel DU-137Model DT-200SModel DI-4000Model DU-337Model DEBS-07Model DS-3000Model DUB-100Model DU-127Model DU-143
Identity
- Trade Name
- Daiwha Corp., Ltd. EUDAMED
- Device Name
- DI-6000V EUDAMEDDT-150S EUDAMEDDU-137 EUDAMEDDT-200S EUDAMEDDI-4000 EUDAMEDDU-337 EUDAMEDDEBS-07 EUDAMEDDS-3000 EUDAMEDDUB-100 EUDAMEDDU-127 EUDAMEDDU-143 EUDAMED
- Model / Reference
- DI-6000V EUDAMEDDW-MTS EUDAMEDDT-150S EUDAMEDDU-137 EUDAMEDDT-200S EUDAMEDDI-4000 EUDAMEDDU-337 EUDAMEDDEBS-07 EUDAMEDDS-3000 EUDAMEDDUB-100 EUDAMEDDU-127 EUDAMEDDU-143 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800009400465 EUDAMED08800009400359 EUDAMED08800009400397 EUDAMED08800009400342 EUDAMED08800009400007 EUDAMED08800009400557 EUDAMED08800009400588 EUDAMED08800009400014 EUDAMED08800009400458 EUDAMED08800009400380 EUDAMED08800009400496 EUDAMED
- Basic UDI-DI
- B-08800009400465 EUDAMEDB-08800009400359 EUDAMEDB-08800009400397 EUDAMEDB-08800009400342 EUDAMEDB-08800009400007 EUDAMEDB-08800009400557 EUDAMEDB-08800009400588 EUDAMEDB-08800009400014 EUDAMEDB-08800009400458 EUDAMEDB-08800009400380 EUDAMEDB-08800009400496 EUDAMED
- EMDN Code
- Z12030301 INFUSION PUMPS EUDAMEDZ12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMEDK0202010201 ULTRASONIC OPEN SURGERY HANDPIECES, SINGLE-USE EUDAMEDK0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMEDZ12030302 SYRINGE PUMPS EUDAMEDK0202010101 ULTRASONIC OPEN SURGERY SCISSORS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Daiwha Corp., Ltd. by Daiwha Corp., 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-08800009400465 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Daiwha Corp., Ltd.
- EUDAMED SRN
- KR-MF-000024402
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (11)
- EUDAMED 0e21e005-2bb1-420a-b706-8336cf779ce6 61 fields · synced Jul 27, 2026
- EUDAMED be933a5d-77fd-4878-a47e-9191200ac1c1 61 fields · synced May 16, 2026
- EUDAMED acfd295c-2036-4edb-9a2e-6756318733c8 61 fields · synced May 17, 2026
- EUDAMED ab652908-c877-4906-bdd8-46b8d272b25b 61 fields · synced May 17, 2026
- EUDAMED 5c841a3b-256f-4901-8a03-5d4f21fa1d1b 61 fields · synced May 17, 2026
- EUDAMED 457af018-f5eb-4096-9399-ca17bc9bd24b 61 fields · synced May 17, 2026
- EUDAMED c164f47c-0190-4503-b671-b47c77012d0c 61 fields · synced May 18, 2026
- EUDAMED df0b03a7-241e-4000-9456-513a7c3c142d 61 fields · synced May 19, 2026
- EUDAMED 144b28fe-5056-4209-8a98-28ebf5f928b0 61 fields · synced May 19, 2026
- EUDAMED 23da776d-b38f-4a94-aadf-2465021d3cb0 61 fields · synced May 19, 2026
- EUDAMED 91965eb7-69f0-41f8-88bc-22322494fbf5 61 fields · synced May 19, 2026