Identity
- Device Name
- Bladeless Dilating Tip Trocar 12mm/150mm EUDAMED
- Model / Reference
- 899313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04714127860633 EUDAMED
- Basic UDI-DI
- B-04714127860633 EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Bladeless Dilating Tip Trocar 12mm/150mm by Unimax Medical Systems 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-04714127860633 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unimax Medical Systems Inc.
- EUDAMED SRN
- TW-MF-000008895
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 43dee6a6-c14b-4235-a67f-2fb82e3b9172 61 fields · synced Jul 12, 2026