Collection Bag
by Fortune Medical Instrument Corp. 3 variants
Ref 2013-9940Model 2013 series, 2015-8601
Active
CE MDR CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberB-04710961934936 04710961934936 | Date6 Feb 2024 | StatusActive |
| European Union | CE/MDD | NumberB-04710961934936 04710961934936 | Date6 Feb 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR, CE/MDD Active
Specification
- Device Name
- Endo Connector
- Model / Reference
- 2013 series, 2013-9940, 2015-8601
- Primary DI / UDI-DI
- 04710961934936
- Basic UDI-DI
- B-04710961934936, 47109619304020103AS
- EMDN Code
- A060301 Collection bags and other containers for drainages and fistulas, single use
- Device Class
- Class I
- EU market of registration
- SpainGermany
Manufacturer details
- EUDAMED SRN
- TW-MF-000009221
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Fortune Medical Instrument Corp.
Properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No