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Coloplast All Silicone Foley Catheter
EUDAMEDClass IIb (EU MDR)
Ref AW6316Model All Silicone Foley Catheter 2-way female, 2-way standard, 2-way open tip, 2-way tiemann, 2-way couvelaire, 2-way dufour, 2-way mercier
Identity
- Trade Name
- Coloplast All Silicone Foley Catheter EUDAMED
- Device Name
- All Silicone Foley Catheter EUDAMED
- Model / Reference
- All Silicone Foley Catheter 2-way female, 2-way standard, 2-way open tip, 2-way tiemann, 2-way couvelaire, 2-way dufour, 2-way mercier EUDAMEDAW6316 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925816627071 EUDAMED
- Basic UDI-DI
- 69449327FF01B00E4 EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Austria 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
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Coloplast All Silicone Foley Catheter by Well Lead Medical Co., Ltd — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- BIP Foley Catheter 2-way, 18 Ch/Fr, 30ml/cc — Bactiguard AB · Class IIb
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 | 69449327FF01B00E4 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000006728
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e4b25295-7dec-4954-8e77-14c800b9b10a 61 fields · synced Jun 18, 2026