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Pre-gelled bag 1000 ml
EUDAMEDClass I (EU MDR)
Ref 57557JPRef 57557-9
by Serres Oy
Identity
- Trade Name
- Pre-gelled bag 1000 ml EUDAMED
- Device Name
- Suction bags EUDAMED
- Model / Reference
- 57557JP EUDAMED57557-9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14544753010327 EUDAMED06418685026811 EUDAMED
- Basic UDI-DI
- 6418685SBS17Q 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
- Finland EUDAMED
Clinical & Handling
Sterile
No
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
Pre-gelled bag 1000 ml by Serres Oy — Class I — MDR — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6418685SBS17Q | Class I | Active |
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Manufacturer
- Manufacturer
- Serres Oy
- EUDAMED SRN
- FI-MF-000004504
Sources (2)
- EUDAMED 01bd6915-d622-4951-ae8a-a76eab8491a5 61 fields · synced Jul 19, 2026
- EUDAMED 6a58b052-27ea-45d7-af4b-eed10bc0cb21 61 fields · synced May 18, 2026