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Silicone Reservoir
EUDAMEDClass I (EU MDR)
Ref SR200STRef SR400STRef SR100SRef SR150STRef SR200SRef SR150SRef SR400S
Identity
- Trade Name
- Silicone Reservoir EUDAMED
- Device Name
- Silicone Reservoir EUDAMED
- Model / Reference
- SR200ST EUDAMEDSR400ST EUDAMEDSR100S EUDAMEDSR150ST EUDAMEDSR200S EUDAMEDSR150S EUDAMEDSR400S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06953676311502 EUDAMED06953676312523 EUDAMED06953676309400 EUDAMED06953676311564 EUDAMED06953676309516 EUDAMED06953676311434 EUDAMED06953676304252 EUDAMED
- Basic UDI-DI
- 69536763SR001UL 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
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Silicone Reservoir by Hangzhou Fushan Medical Appliances Co., Ltd. — 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 | 69536763SR001UL | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Fushan Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000022768
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (7)
- EUDAMED fb5a1652-121b-4657-97ce-c3b9412b33b1 61 fields · synced Aug 2, 2026
- EUDAMED c288ed8d-066e-4037-96a7-02f69bd10e73 61 fields · synced May 16, 2026
- EUDAMED b9850a3e-3d06-469e-8248-e0f2405df2bd 61 fields · synced May 16, 2026
- EUDAMED 841b7c6c-0d4e-4450-9468-30fef36113d3 61 fields · synced May 17, 2026
- EUDAMED 45f34396-e80a-493f-883b-b3fbfa6aa2a7 61 fields · synced May 17, 2026
- EUDAMED a38ffab8-a3e0-4d4a-900c-79b988571b03 61 fields · synced May 18, 2026
- EUDAMED 540502b8-6839-4e30-85fc-1d7bf3d794b3 61 fields · synced May 19, 2026