Identity
- Model / Reference
- Disposable Trocars EUDAMEDSRTI-AL02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973118372113 EUDAMED
- Basic UDI-DI
- B-06973118372113 EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Srti-Al02 by ChangZhou 3R Medical Device Technology Co., Ltd — 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-06973118372113 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ChangZhou 3R Medical Device Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000001123
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 92415feb-8478-4988-b6c4-28adfb66e7e1 61 fields · synced Oct 6, 2026