Identity
- Trade Name
- T.C.S. EUDAMED
- Device Name
- T.C.S. EUDAMED
- Model / Reference
- v1.1 EUDAMEDT.C.S. EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03665324000029 EUDAMED
- Basic UDI-DI
- 3665324TCSV1.1YE EUDAMED
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
T.c.s. by MAK-SYSTEM Group 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 | 3665324TCSV1.1YE | Class A | Active |
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Manufacturer
- Manufacturer
- MAK-SYSTEM Group Ltd.
- EUDAMED SRN
- GB-MF-000026178
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 06c7a48c-cfe6-46c1-8fdd-1765f4ca8a0a 61 fields · synced Jul 9, 2026