Identity
- Device Name
- Pre-Trigger Solution EUDAMED
- Model / Reference
- MCL01302E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926802603666 EUDAMED06926802603673 EUDAMED
- Basic UDI-DI
- 69268026MD71M00001YL EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMEDW01029003 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Pre-Trigger Solution by Medcaptain 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 | 69268026MD71M00001YL | Class A | Active |
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Manufacturer
- Manufacturer
- Medcaptain Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005925
- Authorised Representative
- R Sight B.V. NL-AR-000010445
Sources (4)
- EUDAMED 5b08259f-6abe-416e-8a2a-0b2e41bfe3ca 61 fields · synced Aug 1, 2026
- EUDAMED af1f697c-78f6-4b73-85d5-623aa7232a4e 61 fields · synced May 19, 2026
- EUDAMED 8760f04e-0715-429c-ad66-33e061510088 61 fields · synced Jul 18, 2026
- EUDAMED 7b6187d6-1307-4aa7-8e0e-ad26aeb39251 61 fields · synced Aug 1, 2026