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Suction bag 3000 ml
EUDAMEDFDA UDIClass I (EU MDR)
Ref 57187JPRef 570187-0Ref 57187-9Ref 57167-0Ref 57187-0
by Serres Oy
Identity
- Trade Name
- Suction bag 3000 ml EUDAMEDSuction bag 2000 ml EUDAMEDSuction bag, folded EUDAMEDSuction bag, folded, 3000 ml FDA UDI
- Generic Name
- Suction system canister liner FDA UDI
- Device Name
- Suction bags EUDAMED
- Model / Reference
- 57187JP EUDAMED570187-0 EUDAMEDFDA UDI57187-9 EUDAMED57167-0 EUDAMED57187-0 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14544753001523 EUDAMED06418685062543 EUDAMED06418685021519 EUDAMED06418685013910 EUDAMED06418685014016 EUDAMED06418685047519 FDA UDI
- Basic UDI-DI
- 6418685SBS17Q EUDAMED
- FDA Product Code
- KDQ FDA UDI
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
- GMDN Term
- Suction system canister liner FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
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
Suction bag 3000 ml by Serres Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6418685SBS17Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Serres Oy
- EUDAMED SRN
- FI-MF-000004504
Sources (8)
- EUDAMED 55cf1ee4-2c08-4652-96c0-d25bd0f443bd 61 fields · synced Jul 14, 2026
- EUDAMED f4774ade-2bd4-46b5-adb8-5e1475a3bb7d 61 fields · synced May 17, 2026
- EUDAMED ad54e08b-e914-4a2d-9863-b185b467f1a5 61 fields · synced May 18, 2026
- EUDAMED 2d991d83-2877-464f-858f-4b9a3f3671a4 61 fields · synced May 18, 2026
- EUDAMED c63fe857-d075-4d03-8e51-b056fd509be5 61 fields · synced May 18, 2026
- FDA UDI 223d98c5-7348-4aef-bb11-daa7ffc52b7e 32 fields · synced May 29, 2026
- EUDAMED 4c66b44d-6207-4c42-abbf-36295501a605 61 fields · synced Jun 20, 2026
- EUDAMED 8ed8f0c1-5558-4ed2-aef8-178cf1294e74 61 fields · synced Jul 9, 2026