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Urine drainage bag
EUDAMEDClass I (EU MDR)
Ref HK-B03-W single bagRef HKB01NPNAModel HKB03NTN, HKB04NNN, HKB01NPN, HKB01NPNA, HK-B01, HK-B02, HK-B03, HK-B04, HK-B05, HK-B06, HK-B07, HK-B08, HK-B09, HK-B10Ref HKB03NTNRef HKB01NPNRef HKB03STN
Identity
- Trade Name
- Urine drainage bag EUDAMED
- Device Name
- Urine drainage bag EUDAMED
- Model / Reference
- HK-B03-W single bag EUDAMEDHKB03NTN, HKB04NNN, HKB01NPN, HKB01NPNA, HK-B01, HK-B02, HK-B03, HK-B04, HK-B05, HK-B06, HK-B07, HK-B08, HK-B09, HK-B10 EUDAMEDHKB01NPNA EUDAMEDHKB03NTN EUDAMEDHKB01NPN EUDAMEDHKB03STN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945934601920 EUDAMED06945934602927 EUDAMED06945934602064 EUDAMED06945934602910 EUDAMED06945934603160 EUDAMED
- Basic UDI-DI
- B-06945934601920 EUDAMED69459346udbGQ EUDAMEDB-06945934603160 EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMEDSpain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Urine drainage bag by Changzhou Huankang Medical Device Co., Ltd. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06945934601920 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-06945934601920 | 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 (5)
- EUDAMED 5cd42e55-8fad-4870-a36b-3e04e8c7aaa7 61 fields · synced Oct 6, 2026
- EUDAMED d72ecfc2-13e2-434e-bbc7-aaba7bd5a39e 61 fields · synced May 16, 2026
- EUDAMED 15a6ed05-c073-4e2a-bde3-19834b288d3c 61 fields · synced May 17, 2026
- EUDAMED b1716cd7-3ffd-4f95-ba45-be92c2908a8e 61 fields · synced May 17, 2026
- EUDAMED adb8e0f9-d19e-4c17-8bef-eb360c0445db 61 fields · synced Jul 9, 2026