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Penilex Silicone
EUDAMEDClass I (EU MDR)
Ref PA5235Ref PA7040Ref PA6032Ref PA6225Ref PA7035Ref PA7230Ref PA7240Ref PA7225Ref PA6035Ref PA7232Ref PA6040Ref PA7235Ref PA5232Ref PA7032Ref PA6030Ref PA6232Ref PA7030
Identity
- Trade Name
- Penilex Silicone EUDAMED
- Device Name
- Penilex Silicone self-sealing urisheath EUDAMED
- Model / Reference
- PA5235 EUDAMEDPA7040 EUDAMEDPA6032 EUDAMEDPA6225 EUDAMEDPA7035 EUDAMEDPA7230 EUDAMEDPA7240 EUDAMEDPA7225 EUDAMEDPA6035 EUDAMEDPA7232 EUDAMEDPA6040 EUDAMEDPA7235 EUDAMEDPA5232 EUDAMEDPA7032 EUDAMEDPA6030 EUDAMEDPA6232 EUDAMEDPA7030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03600040325315 EUDAMED03600040252178 EUDAMED03600040251928 EUDAMED03600040325346 EUDAMED03600040252147 EUDAMED03600040324769 EUDAMED03600040324851 EUDAMED03600040325407 EUDAMED03600040251973 EUDAMED03600040324790 EUDAMED03600040252024 EUDAMED03600040325438 EUDAMED03600040324493 EUDAMED03600040252116 EUDAMED03600040251874 EUDAMED03600040324646 EUDAMED03600040252086 EUDAMED
- Basic UDI-DI
- 57089322978419A EUDAMED
- EMDN Code
- U070201 SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Penilex Silicone by Coloplast A/S — 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 | 57089322978419A | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (17)
- EUDAMED 1aa08786-5dea-4fc5-b19c-20d2c65c536d 61 fields · synced Sep 18, 2026
- EUDAMED a9c86b37-3b0e-4fb5-ae96-1581d418dfb4 61 fields · synced May 16, 2026
- EUDAMED f9e7ff7e-b6de-4ac4-8b90-98230578f612 61 fields · synced May 17, 2026
- EUDAMED 80ae14d5-4324-4f5f-8389-a7da3e8c645f 61 fields · synced May 17, 2026
- EUDAMED 725c2880-6d10-4267-961e-8ae3b44f6f37 61 fields · synced May 17, 2026
- EUDAMED 4e0e25a7-3339-42bd-96fe-8fde7e878166 61 fields · synced May 17, 2026
- EUDAMED 71cad83f-5554-4823-ae7c-27737aa6365a 61 fields · synced May 17, 2026
- EUDAMED c1b93012-b41a-4014-b2ca-7e65cf69622b 61 fields · synced May 17, 2026
- EUDAMED 6755a312-1dc8-447f-8d4b-ad7c5cc1b565 61 fields · synced May 17, 2026
- EUDAMED 1027ea45-8d07-4075-b054-4998ea0379ae 61 fields · synced May 17, 2026
- EUDAMED cf3d31b3-890f-4d3c-a4e6-d7ee60396826 61 fields · synced May 18, 2026
- EUDAMED 2ce4b3e8-097d-480b-a71a-1302211a86a1 61 fields · synced May 18, 2026
- EUDAMED caa21097-160b-4f1c-ad40-56cc31545c1b 61 fields · synced May 18, 2026
- EUDAMED e8a78325-3d29-45be-b0a4-c2cbe01dbd95 61 fields · synced May 18, 2026
- EUDAMED 71cd9af8-9ce7-4107-9bca-fd382825b17f 61 fields · synced May 18, 2026
- EUDAMED 136a4f66-fc05-425b-b0ed-99a72556987d 61 fields · synced May 18, 2026
- EUDAMED c862ed88-1fc5-46c4-9af8-2323fc902485 61 fields · synced May 19, 2026