Identity
- Trade Name
- Pre-gelled bag 1000 ml EUDAMEDPre-gelled bag, 1000 ml FDA UDI
- Generic Name
- Suction system canister liner FDA UDI
- Device Name
- Suction bags EUDAMED
- Model / Reference
- 570557 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06418685062550 EUDAMED06418685047618 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
Pre-gelled bag 1000 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 (2)
- EUDAMED dcd9cc9a-2978-440c-83a7-5656189b6e5e 61 fields · synced Jun 18, 2026
- FDA UDI fae1155b-e6f6-47de-a165-f71ca096ac92 32 fields · synced May 30, 2026