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Silicone C.W.V. Reservoir
EUDAMEDClass I (EU MDR)
Ref 2013-0910Model 2013 series
Identity
- Trade Name
- Silicone C.W.V. Reservoir EUDAMED
- Device Name
- Silicone C.W.V. Reservoir EUDAMED
- Model / Reference
- 2013 series EUDAMED2013-0910 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961934882 EUDAMED
- Basic UDI-DI
- B-04710961934882 EUDAMED
- EMDN Code
- A0601010199 DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Silicone C.W.V. Reservoir by Fortune Medical Instrument Corp. — Class I — 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-04710961934882 | Class I | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d6f58d18-3ebd-4d3c-a04d-adb6e5712b36 61 fields · synced May 23, 2026