Pre-gelled bag 1000 ml
EUDAMEDFDA UDIClass I (EU MDR)
by Serres Oy
Identity
- Trade Name
- Pre-gelled bag 1000 ml EUDAMEDPre-gelled bag 2000 ml EUDAMEDPre-gelled bag EUDAMEDPre-gelled bag, folded, 2000 ml FDA UDI
- Generic Name
- Suction system canister liner FDA UDI
- Device Name
- Suction bags EUDAMED
- Model / Reference
- 57557 EUDAMED57577 EUDAMED57567-9 EUDAMED570567-0 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06418685557018 EUDAMED06418685028525 EUDAMED06418685026910 EUDAMED06418685062567 EUDAMED06418685047014 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 1000 ml by Serres Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system canister.
- Webura — WEIHAI WEIBO MEDICAL TECHNOLOGY CO.,LTD · Class I
- PLASTI-MED — Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. · Class I
- Sacca 600 ml circuito chiuso s/rubinetto — Redax S.p.A. · Class I
- Webura — WEIHAI WEIBO MEDICAL TECHNOLOGY CO.,LTD · Class I
- Suction liner 2000ML (without shut-off filter, pre-loaded SAP) — Yung Kang Medical Device Technology Co., Ltd. · Class I
- YDC Suction liner with shutoff filter with solidifying agent 2000ml — Shijiazhuang Yuanding Medical Device Co.,LTD · Class I
- Sacca 600 ml circuito chiuso c/filtro — Redax S.p.A. · Class I
- PLASTI-MED — Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Serres Oy
- EUDAMED SRN
- FI-MF-000004504
Sources (6)
- EUDAMED ec376b2a-0d2a-485b-9cd1-ea2bf233319f 61 fields · synced Jul 24, 2026
- EUDAMED a52601ba-0ef8-49cc-86b9-97b2663f9c82 61 fields · synced May 16, 2026
- EUDAMED d231746f-cdf4-4f4e-9c64-29341b857470 61 fields · synced May 19, 2026
- EUDAMED 0cb337ba-c8f0-48fc-9ace-2e77da1c717d 61 fields · synced May 19, 2026
- FDA UDI 05efd025-7383-4dac-b888-54ee7523f284 32 fields · synced May 30, 2026
- EUDAMED 3ddb6d92-7af4-4771-87d2-fd75adb99ac8 61 fields · synced Jul 13, 2026