Identity
- Trade Name
- MONOTELO TUR EUDAMED
- Device Name
- CUSTOM PACK CHIRURGIA GENERALE - RADIOLOGIA EUDAMED
- Model / Reference
- TE-CS-370C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08054042880184 EUDAMED
- Basic UDI-DI
- 805404288TECSDU EUDAMED
- EMDN Code
- T020102,T0202 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Monotelo Tur by C.a.m. Hospital — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805404288TECSDU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cam Hospital srl
- EUDAMED SRN
- IT-MF-000033797
Sources (1)
- EUDAMED 564f43a6-05d5-4559-971e-585aebbb039f 61 fields · synced Jun 19, 2026