Identity
- Trade Name
- Detachable Blade, 3 cm EUDAMED
- Device Name
- Detachable Blade, 3 cm EUDAMED
- Model / Reference
- 1011116 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1011116TB EUDAMED
- Basic UDI-DI
- B-1011116TB EUDAMED
- EMDN Code
- L0804,L08060299 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Detachable Blade, 3 cm by Coroneo Inc — Class IIa — 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-1011116TB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Coroneo Inc.
- EUDAMED SRN
- CA-MF-000019141
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED c858f5b4-102d-4e84-a577-2851639c7047 61 fields · synced Jul 20, 2026