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8fg x 47cm Double Lumen Cystometry Catheter with Tiemann Tip (15cm)
EUDAMEDClass IIa (EU MDR)
Ref 100080032
by Malvern Medical Developments Ltd also trading as PB Medical Ltd
Identity
- Device Name
- 8fg x 47cm Double Lumen Cystometry Catheter with Tiemann Tip (15cm) EUDAMED
- Model / Reference
- 100080032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436037135453 EUDAMED
- Basic UDI-DI
- B-08436037135453 EUDAMED
- EMDN Code
- U05010101 CYSTOMANOMETRY CATHETERS, WITHOUT BALLOON, 2-WAY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
8fg x 47cm Double Lumen Cystometry Catheter with Tiemann Tip (15cm) by Malvern Medical Developments Ltd also trading as PB Medical Ltd — Class IIa — MDD…
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-08436037135453 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- GB-MF-000014481
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED fa33626a-f076-4b69-a8a4-f1c63881d7dd 61 fields · synced Oct 6, 2026