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Hygion
EUDAMEDClass I (EU MDR)
Ref HYG-UM400Model 2000+200ml，2000+350ml，2000+400ml，2000+500ml，2500+200ml，2500+350ml，2500+400ml，2500+500ml，2600+200ml，2600+350ml，2600+400ml，2600+500ml，3000+200ml，3000+350ml，3000+400ml，3000+500ml，3500+500ml
Identity
- Trade Name
- HYGION EUDAMED
- Model / Reference
- 2000+200ml，2000+350ml，2000+400ml，2000+500ml，2500+200ml，2500+350ml，2500+400ml，2500+500ml，2600+200ml，2600+350ml，2600+400ml，2600+500ml，3000+200ml，3000+350ml，3000+400ml，3000+500ml，3500+500ml EUDAMEDHYG-UM400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972374226048 EUDAMED
- Basic UDI-DI
- 69723742202W4 EUDAMED
- Direct Marketing DI
- 06972374226048 EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hygion by Changshu Wilson Medical Devices Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69723742202W4 | Class I | Active |
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Manufacturer
- Manufacturer
- Changshu Wilson Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000032020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 5f8e0dfd-8ddf-4193-999d-abae846f2216 61 fields · synced Jun 19, 2026