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Urine drainage bag
EUDAMEDClass I (EU MDR)
Ref HKB03NTNModel HKB03NTN, HKB04NNN, HKB01NPN, HKB01NPNA, HK-B01, HK-B02, HK-B03, HK-B04, HK-B05, HK-B06, HK-B07, HK-B08, HK-B09, HK-B10
Identity
- Trade Name
- Urine drainage bag EUDAMED
- Device Name
- Urine Drainage Bag EUDAMED
- Model / Reference
- HKB03NTN, HKB04NNN, HKB01NPN, HKB01NPNA, HK-B01, HK-B02, HK-B03, HK-B04, HK-B05, HK-B06, HK-B07, HK-B08, HK-B09, HK-B10 EUDAMEDHKB03NTN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945934603016 EUDAMED
- Basic UDI-DI
- 69459346udbGQ EUDAMED
- EMDN Code
- A06030301 URINE COLLECTION BAGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
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 — 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 | 69459346udbGQ | 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 (2)
- EUDAMED 3ef6fdc0-0074-4932-b09c-b45f95568f49 61 fields · synced Jun 18, 2026
- EUDAMED 782679ab-b99e-4601-bf86-506b3abc83b7 61 fields · synced Jun 18, 2026