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Orcl Medical
EUDAMEDClass IIa (EU MDR)
Ref 90880301Model 2-way Paediatric:6FrRef 90880001Model 6Fr、8Fr、10Fr、12Fr、14Fr 16Fr、18Fr、20Fr、22Fr
Identity
- Trade Name
- ORCL MEDICAL EUDAMED
- Device Name
- Silicone Foley Catheter EUDAMEDStomach Tube EUDAMED
- Model / Reference
- 2-way Paediatric:6Fr EUDAMED90880301 EUDAMED6Fr、8Fr、10Fr、12Fr、14Fr 16Fr、18Fr、20Fr、22Fr EUDAMED90880001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972745361408 EUDAMEDD-CN-MF-000039222T5 EUDAMED
- Basic UDI-DI
- B-06972745361408 EUDAMEDB-CN-MF-000039222T5 EUDAMED
- EMDN Code
- U010201 URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON EUDAMEDG02020101 NASOGASTRIC TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
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
Orcl Medical 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-06972745361408 | 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 (2)
- EUDAMED eea733b6-991b-4923-8e8a-c014042271d1 61 fields · synced Oct 5, 2026
- EUDAMED eef96d74-fcfa-4ee8-a8b4-7593b518553d 61 fields · synced May 17, 2026