Identity
- Device Name
- Disposable Trocars EUDAMED
- Model / Reference
- SRTF-AM02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973118371864 EUDAMED
- Basic UDI-DI
- B-06973118371864 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
Disposable Trocars 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-06973118371864 | 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 28105f80-6072-48a7-86db-a7c64910c1a2 61 fields · synced Jun 18, 2026