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8 Spirally Aligned Channels with Balloon, 3.9mm
EUDAMEDClass IIa (EU MDR)
Ref 500039034Model AHB5374Ref 500039048Model AHB5291
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- 8 Spirally Aligned Channels with Balloon, 3.9mm EUDAMED
- Model / Reference
- AHB5374 EUDAMED500039034 EUDAMEDAHB5291 EUDAMED500039048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060166520885 EUDAMED05060166520878 EUDAMED
- Basic UDI-DI
- B-05060166520885 EUDAMEDB-05060166520878 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
8 Spirally Aligned Channels with Balloon, 3.9mm 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-05060166520885 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 663f114f-050b-44fb-a89f-ac3ad5aab9bd 61 fields · synced Oct 7, 2026
- EUDAMED 88d53fe3-4ee6-40ba-ac4e-330f0b428196 61 fields · synced May 16, 2026