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Collection Bag
EUDAMEDClass I (EU MDR)
Ref 2013-9980Model 2013 seriesRef 2013-9920Model 2013 seriesRef 2013-9940Model 2015-8601
Identity
- Trade Name
- Collection Bag EUDAMED
- Device Name
- Collection Bag EUDAMEDENDO CONNECTOR EUDAMED
- Model / Reference
- 2013 series EUDAMED2013-9980 EUDAMED2013-9920 EUDAMED2013-9940 EUDAMED2015-8601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710961934943 EUDAMED04710961934929 EUDAMED04710961934936 EUDAMED
- Basic UDI-DI
- B-04710961934943 EUDAMEDB-04710961934929 EUDAMEDB-04710961934936 EUDAMED47109619304020103AS EUDAMED
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Negative-pressure wound therapy system canister
Collection Bag by Fortune Medical Instrument Corp. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04710961934943 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-04710961934943 | 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 (6)
- EUDAMED 4a5316e4-05d7-45da-b792-5c60403edafd 61 fields · synced Jul 23, 2026
- EUDAMED 9c856a3c-0ff9-4086-8cc0-43b23e13839a 61 fields · synced May 18, 2026
- EUDAMED 4743ee3e-83e3-4f61-b3ab-cf9ee7a01539 61 fields · synced May 18, 2026
- EUDAMED 81f1f595-d33a-4a08-8220-f640add73a4f 61 fields · synced Jun 19, 2026
- EUDAMED e62bd191-258d-484a-9618-4066351a0fac 61 fields · synced Jun 20, 2026
- EUDAMED 835f9d9c-4d90-40eb-bfb5-00a59f76eb7f 61 fields · synced Jul 17, 2026