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4.5fg Rectal Poly-Isoprene Balloon Catheter with Introducer
EUDAMEDClass IIa (EU MDR)
Ref 200045017
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- 4.5fg Rectal Poly-Isoprene Balloon Catheter with Introducer EUDAMED
- Model / Reference
- 200045017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166521684 EUDAMED
- Basic UDI-DI
- B-05060166521684 EUDAMED
- EMDN Code
- U050402 INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
4.5fg Rectal Poly-Isoprene Balloon Catheter with Introducer by Malvern Medical Developments Ltd also trading as PB Medical Ltd — Class IIa — MDD — listed in…
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-05060166521684 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 09a45bf5-7d2b-4f85-811c-d020edb921fd 61 fields · synced Jun 18, 2026