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urine drainage bag - pediatric urine collector
EUDAMEDClass I (EU MDR)
Ref HK-B06
Identity
- Trade Name
- urine drainage bag - pediatric urine collector EUDAMED
- Device Name
- Urine drainage bag EUDAMED
- Model / Reference
- HK-B06 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69459346HKB06T2SH EUDAMED
- Basic UDI-DI
- B-69459346HKB06T2SH EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
urine drainage bag - pediatric urine collector by Changzhou Huankang Medical Device Co., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-69459346HKB06T2SH | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Huankang Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000009030
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5c4ee135-6f69-4aee-95d8-849d45c0c88d 61 fields · synced Oct 8, 2026