Pre-gelled bag 3000 ml
EUDAMEDFDA UDIClass I (EU MDR)
by Serres Oy
Identity
- Trade Name
- Pre-gelled bag 3000 ml EUDAMEDPre-gelled bag, folded, 3000 ml FDA UDI
- Generic Name
- Suction system canister liner FDA UDI
- Device Name
- Suction bags EUDAMED
- Model / Reference
- 570587-0 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06418685062574 EUDAMED06418685047717 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
Single Use
Yes
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Negative-pressure wound therapy system canister
Pre-gelled bag 3000 ml by Serres Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 (2)
- EUDAMED 35c42c00-793f-495a-ba45-f8f9812d113b 61 fields · synced Jul 18, 2026
- FDA UDI 6f371042-e212-4f12-a2bd-123489f89102 32 fields · synced May 30, 2026