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Silicone Foley Catheter
EUDAMEDClass IIa (EU MDR)
Ref 91030017Ref 91030014Model 3-way Standard: 16FRef 91030016Model 3-way Standard: 20FrRef 91030009Model 2-way Standard: 22FrRef 91030004Model 2-way Standard: 12FrRef 91030012Model 3-way Standard: 12FrRef 9030002Model 2-way Paediatric: 8FRef 91030006Model 2-way Standard: 16FrRef 91030011Model 2-way Standard: 26FrRef 91030003Model 2-way Paediatric:10FrRef 91030019Model 3-way Standard: 26FrRef 91030015Model 3-way Standard: 18F
Identity
- Trade Name
- Silicone Foley Catheter EUDAMED
- Device Name
- Silicone Foley Catheter EUDAMED
- Model / Reference
- 91030017 EUDAMED3-way Standard: 16F EUDAMED91030014 EUDAMED3-way Standard: 20Fr EUDAMED91030016 EUDAMED2-way Standard: 22Fr EUDAMED91030009 EUDAMED2-way Standard: 12Fr EUDAMED91030004 EUDAMED3-way Standard: 12Fr EUDAMED91030012 EUDAMED2-way Paediatric: 8F EUDAMED9030002 EUDAMED2-way Standard: 16Fr EUDAMED91030006 EUDAMED2-way Standard: 26Fr EUDAMED91030011 EUDAMED2-way Paediatric:10Fr EUDAMED91030003 EUDAMED3-way Standard: 26Fr EUDAMED91030019 EUDAMED3-way Standard: 18F EUDAMED91030015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972745361620 EUDAMED06972745361590 EUDAMED06972745361613 EUDAMED06972745361521 EUDAMED06972745361446 EUDAMED06972745361576 EUDAMED06972745361439 EUDAMED06972745361477 EUDAMED06972745361545 EUDAMED06972745361422 EUDAMED06972745361644 EUDAMED06972745361606 EUDAMED
- Basic UDI-DI
- B-06972745361620 EUDAMEDB-06972745361590 EUDAMEDB-06972745361613 EUDAMEDB-06972745361521 EUDAMEDB-06972745361446 EUDAMEDB-06972745361576 EUDAMEDB-06972745361439 EUDAMEDB-06972745361477 EUDAMEDB-06972745361545 EUDAMEDB-06972745361422 EUDAMEDB-06972745361644 EUDAMEDB-06972745361606 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMEDU020101 URETERAL CATHETERS WITH CYLINDRICAL TIP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDFinland EUDAMEDIreland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Foley Catheter by Guangzhou Orcl Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972745361620 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Orcl Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039222
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (12)
- EUDAMED 866d3305-b307-41e1-9583-abe9524e2f19 61 fields · synced Aug 3, 2026
- EUDAMED 3aaf02c9-d68d-4949-a339-bae46e970795 61 fields · synced May 16, 2026
- EUDAMED a54c2a45-a674-487d-9478-92589b9d989f 61 fields · synced May 17, 2026
- EUDAMED 5d199e6d-28aa-4326-946c-1fb9fd9fa218 61 fields · synced May 17, 2026
- EUDAMED 21b3be95-6ad3-4953-a6c4-2e388342ba53 61 fields · synced May 17, 2026
- EUDAMED b8d72958-8722-4430-90ab-dd231c8d4b39 61 fields · synced May 18, 2026
- EUDAMED ac9677de-2295-474f-b176-f962e51527de 61 fields · synced May 18, 2026
- EUDAMED 440fc6f6-56ba-4066-ac45-e46540344797 61 fields · synced May 18, 2026
- EUDAMED 75aab74a-d69a-48b9-b049-0c20a05f099b 61 fields · synced May 18, 2026
- EUDAMED 24875759-592a-4ad0-934c-a0e49ef33cf5 61 fields · synced May 18, 2026
- EUDAMED 5397e56e-a132-4915-8059-bfbb2bd8def9 61 fields · synced May 19, 2026
- EUDAMED 20c8c033-d041-4ebb-9317-bcd77817ac65 61 fields · synced May 19, 2026