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MCM Sheath
EUDAMEDClass A (EU MDR)
Ref 410204011Model MA-500 and CM series urinalysis systemRef 410204016Ref 410204021Ref 410204015Ref 410204024Ref 410204022
Identity
- Device Name
- MCM Sheath EUDAMED
- Model / Reference
- MA-500 and CM series urinalysis system EUDAMED410204011 EUDAMED410204016 EUDAMED410204021 EUDAMED410204015 EUDAMED410204024 EUDAMED410204022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974235033628 EUDAMED06974235033673 EUDAMED06974235033765 EUDAMED06974235033666 EUDAMED06974235033796 EUDAMED06974235033772 EUDAMED
- Basic UDI-DI
- 697423503UMA0004JX EUDAMED
- Direct Marketing DI
- 06974235033628 EUDAMED06974235033673 EUDAMED06974235033765 EUDAMED06974235033666 EUDAMED06974235033796 EUDAMED06974235033772 EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
MCM Sheath by Changchun Medicside Medical Technology 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697423503UMA0004JX | Class A | Active |
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Manufacturer
- Manufacturer
- Changchun Medicside Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000022835
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (6)
- EUDAMED c6da3748-a858-488d-be63-b0f72c8f81ba 61 fields · synced Jul 30, 2026
- EUDAMED 6bc06b8c-81ab-45da-a310-a5581d072057 61 fields · synced May 18, 2026
- EUDAMED e4bf4906-9540-42e7-94af-cc1f6b384e90 61 fields · synced May 19, 2026
- EUDAMED 226a168b-cb43-49b6-917a-02c3e42b280a 61 fields · synced May 19, 2026
- EUDAMED 4fe809e0-4fa0-4bc0-ab47-e195db773acd 61 fields · synced May 19, 2026
- EUDAMED ce635801-acc5-4987-a4de-1e58e0939505 61 fields · synced May 19, 2026