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Mixmax
EUDAMEDClass IIb (EU MDR)
Ref SWMX-CMS--01Ref SWMX-MS-01Ref SWMX-CMS-02Ref SWMX-MS-02
Identity
- Trade Name
- MIXMAX EUDAMED
- Device Name
- MIXMAX EUDAMED
- Model / Reference
- SWMX-CMS--01 EUDAMEDSWMX-MS-01 EUDAMEDSWMX-CMS-02 EUDAMEDSWMX-MS-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272562764 EUDAMED08809272564119 EUDAMED08809272564010 EUDAMED08809272564126 EUDAMED
- Basic UDI-DI
- B-08809272562764 EUDAMEDB-08809272564119 EUDAMEDB-08809272564010 EUDAMEDB-08809272564126 EUDAMED
- EMDN Code
- P099001 ORTHOPAEDIC PROSTHESES CEMENTS AND ACCESSORIES FOR MIXING EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMEDEUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mixmax by Seawon Meditech 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-08809272562764 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Seawon Meditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000007442
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 7e29092e-5acf-4d56-bf4a-4023adc810bf 61 fields · synced Aug 2, 2026
- EUDAMED f85300d7-ff93-4bf0-adc8-27abe1e1084c 61 fields · synced May 17, 2026
- EUDAMED 60a68550-0766-4ec1-8f72-b5d91e523dad 61 fields · synced May 18, 2026
- EUDAMED 615e78c3-a277-4573-8624-378fca2930b7 61 fields · synced May 19, 2026