Identity
- Device Name
- Disposable Fascial Closure Systems EUDAMED
- Model / Reference
- SRDFCS-A-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973118370027 EUDAMED
- Basic UDI-DI
- B-06973118370027 EUDAMED
- EMDN Code
- K01020116 ENDOSCOPIC TISSUE SUTURE APPROXIMATORS, 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 Fascial Closure Systems 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-06973118370027 | 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 32d7541f-87d3-4372-8b3d-05997806d9a4 61 fields · synced Jun 19, 2026