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Silicone C.W.V. Reservoir
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2013-0640Model 2013 seriesRef 2013-0915Ref 2013-0615Ref 2013-0610Ref 2013-0620Ref 2013-0940Model 2015-8601Ref 2013-0920
Identity
- Trade Name
- Silicone C.W.V. Reservoir EUDAMEDFDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- Silicone C.W.V. Reservoir EUDAMEDENDO CONNECTOR EUDAMED
- Model / Reference
- 2013 series EUDAMED2013-0640 EUDAMED2013-0915 EUDAMED2013-0615 EUDAMEDFDA UDI2013-0610 EUDAMEDFDA UDI2013-0620 EUDAMED2013-0940 EUDAMED2015-8601 EUDAMED2013-0920 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961934868 EUDAMED04710961934899 EUDAMED04710961934844 EUDAMED04710961934837 EUDAMED04710961934851 EUDAMED04710961934912 EUDAMED14710961934841 EUDAMEDFDA UDI14710961934834 EUDAMEDFDA UDI44710961934835 EUDAMED54710961934849 EUDAMED24710961934848 EUDAMED04710961934905 EUDAMED
- Basic UDI-DI
- B-04710961934868 EUDAMEDB-04710961934899 EUDAMEDB-04710961934844 EUDAMEDB-04710961934837 EUDAMEDB-04710961934851 EUDAMEDB-04710961934912 EUDAMEDB-44710961934835 EUDAMEDB-54710961934849 EUDAMEDB-24710961934848 EUDAMEDB-14710961934834 EUDAMED47109619304020103AS EUDAMEDB-04710961934905 EUDAMEDB-14710961934841 EUDAMED
- FDA Product Code
- GCY FDA UDI
- EMDN Code
- A0601010199 DRAINAGE SYSTEMS WITH PREDEFINED SUCTION - OTHER EUDAMED
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4680 FDA UDI
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Silicone C.W.V. Reservoir by Fortune Medical Instrument Corp. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04710961934868 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04710961934868 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 (15)
- EUDAMED 23f7eaeb-4c36-47e7-b073-b5a646e2661a 61 fields · synced Jul 28, 2026
- EUDAMED 8c8e80c7-e811-4e0a-9383-39fa95e64a53 61 fields · synced May 17, 2026
- EUDAMED 85c2e4da-e87e-4f80-9c0c-0929b0d278c8 61 fields · synced May 17, 2026
- EUDAMED aa1de399-36b8-456e-9de6-544748a57f3e 61 fields · synced May 18, 2026
- EUDAMED bfc27e19-54d8-47a8-869d-d60ba7c3dd27 61 fields · synced May 18, 2026
- EUDAMED ddabd038-45e4-42e0-a2ff-82813b8e07d7 61 fields · synced May 18, 2026
- FDA UDI baea368b-bec9-4962-bc0a-0c8571b6e9e2 32 fields · synced May 30, 2026
- FDA UDI a34d9cc6-ffa4-409a-ad20-76cbef7f017a 32 fields · synced May 30, 2026
- EUDAMED d8ebe37f-1ccb-4647-996c-ff99215b2fc0 61 fields · synced Jun 20, 2026
- EUDAMED e73bda3a-7552-4128-8b70-1415eaa12997 61 fields · synced Jul 9, 2026
- EUDAMED 052a3ef6-a0f0-4e6e-b710-757444b78297 61 fields · synced Jul 11, 2026
- EUDAMED a192ae98-f9bd-43fc-ae33-92d5d046a2c8 61 fields · synced Jul 12, 2026
- EUDAMED 86a23294-6ffc-4045-9bac-42ad9aa22491 61 fields · synced Jul 17, 2026
- EUDAMED d30da62a-0fca-4ed3-bd7c-82ab523823bf 61 fields · synced Jul 19, 2026
- EUDAMED 308a448f-a2d2-4b31-89f7-2e15d0f6b694 61 fields · synced Jul 28, 2026