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200cm Rectal PVC Balloon Catheter, 4.5 CH
EUDAMEDClass IIa (EU MDR)
Ref 200045025Model MA001145
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- 200cm Rectal PVC Balloon Catheter, 4.5 CH EUDAMED
- Model / Reference
- MA001145 EUDAMED200045025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166522421 EUDAMED
- Basic UDI-DI
- B-05060166522421 EUDAMED
- EMDN Code
- U050402 INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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
200cm Rectal PVC Balloon Catheter, 4.5 CH 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-05060166522421 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e04b953a-9ff7-4f10-8c1d-c015351abff8 61 fields · synced Jul 16, 2026