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Male External Catheter
EUDAMEDClass I (EU MDR)
Ref PU120203Model LatexRef PU120204Ref PU121104Model SiliconeRef PU120104Ref PU121103Ref PU120103Ref PU120101Ref PU120202Ref PU120201
Identity
- Trade Name
- Male External Catheter EUDAMED
- Device Name
- Male External Catheter EUDAMED
- Model / Reference
- Latex EUDAMEDPU120203 EUDAMEDPU120204 EUDAMEDSilicone EUDAMEDPU121104 EUDAMEDPU120104 EUDAMEDPU121103 EUDAMEDPU120103 EUDAMEDPU120101 EUDAMEDPU120202 EUDAMEDPU120201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923310915748 EUDAMED06923310915755 EUDAMED06923310915793 EUDAMED06923310915717 EUDAMED06923310915786 EUDAMED06923310915700 EUDAMED06923310915687 EUDAMED06923310915731 EUDAMED06923310915724 EUDAMED
- Basic UDI-DI
- 69233109PU1201F9 EUDAMED69233109PU1211FC EUDAMED
- EMDN Code
- U070201 SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE 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
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
Male External Catheter by Hangzhou Formed 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 | 69233109PU1201F9 | Class I | Active |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (9)
- EUDAMED 398a354e-300b-4b0c-8dec-01913eeec15e 61 fields · synced Sep 18, 2026
- EUDAMED a61cdd1d-76df-4045-aea6-631140f0cf30 61 fields · synced May 16, 2026
- EUDAMED 7782c635-5ce0-4530-b414-f78e167109cb 61 fields · synced May 17, 2026
- EUDAMED 41d29712-627f-4953-a63b-212ae40ea01b 61 fields · synced May 17, 2026
- EUDAMED 8281a8be-68c2-477d-8669-900e43245c62 61 fields · synced May 17, 2026
- EUDAMED 1fc816db-76ac-4fa1-a06f-9b6faa84eedf 61 fields · synced May 17, 2026
- EUDAMED b8dd5bcf-5527-4c19-9e3c-a45c3d474cd3 61 fields · synced May 17, 2026
- EUDAMED 2e0804a7-087a-4880-9530-399748d6d220 61 fields · synced May 18, 2026
- EUDAMED 03a2e7d0-9615-45d3-ad52-5b9cb8165038 61 fields · synced May 18, 2026