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SondeAR - Air Charged Catheter
EUDAMEDClass IIa (EU MDR)
Ref 500060002Model SAR-AC
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- SondeAR - Air Charged Catheter EUDAMED
- Model / Reference
- SAR-AC EUDAMED500060002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166520175 EUDAMED
- Basic UDI-DI
- B-05060166520175 EUDAMED
- EMDN Code
- G02060305 COLORECTAL MANOMETRY CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
SondeAR - Air Charged Catheter by Malvern Medical Developments Ltd also trading as PB Medical Ltd — Class IIa — MDD — listed in EUDAMED
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-05060166520175 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 174e8fe6-a750-432a-a628-2fddad6aa0cc 61 fields · synced Oct 6, 2026