Question 1

What types of devices does Malvern Medical Developments Ltd manufacture?

Accepted Answer

Malvern Medical Developments Ltd, also trading as PB Medical Ltd, manufactures single-use absorbent tip applicators and swabs, as well as a range of catheters for gastrointestinal and urological diagnostics. These include anorectal and oesophageal manometry catheters with balloons, bladder filling catheters, cystometry catheters, and urethral pressure profile catheters in various lumen configurations and sizes.

The company's devices are classified as Class I and Class IIa under the EU regulatory framework and are listed in the Eudamed database. The manufacturer is based in the United Kingdom (GB).

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Malvern Medical Developments Ltd based?

Accepted Answer

Malvern Medical Developments Ltd is based in the United Kingdom, as indicated by the country code GB in the device data, which specifies the company's location without referencing any approval status or additional operational details.

Question 3

In which regulatory registry are the devices of Malvern Medical Developments Ltd listed?

Accepted Answer

The devices of Malvern Medical Developments Ltd are listed in the Eudamed database, as explicitly stated in the LISTED IN field of the device data, which confirms the registry without implying any form of company-wide approval or certification.

Question 4

How are the devices manufactured by Malvern Medical Developments Ltd classified under EU regulations?

Accepted Answer

The devices manufactured by Malvern Medical Developments Ltd are classified as Class I and Class IIa under the EU regulatory framework, as specified in the DEVICE CLASSES field, which reflects the risk-based classification of individual devices, not the company itself.

Device	Model / Reference	Registries	Class	Status
4 Channel Anorectal Manometry Catheter with Balloon, 4.9mm	500049031	EUDAMED	Class IIa	Active
Female Catheter Pack	300100018	EUDAMED	Class IIa	Active
8 Channel Vector Anorectal Manometry Catheter with Balloon, 4.9mm	500049060	EUDAMED	Class IIa	Active
200cm Rectal Poly-Isoprene Balloon Catheter with Introducer, 4.5 CH	200045028	EUDAMED	Class IIa	Active
1 Lumen Catheter for Rectal Pressure, 8fr	200080001	EUDAMED	Class IIa	Active
Oracol Swab	S11	EUDAMEDFDA UDI	Class I	Active
8 Channel Manometry Catheter, 3.9mm	500039015	EUDAMED	Class IIa	Active
Infusion Set for H2O Pump	400120044	EUDAMED	Class IIa	Active
8 Channel Anorectal Manometry Catheter With Balloon, 3.9mm	500039056	EUDAMED	Class IIa	Active
Pump Tube Set for Laborie Urodynamic Systems	400120001	EUDAMED	Class IIa	Active
8fg x 47cm Double Lumen Cystometry Catheter with Tiemann Tip (15cm)	100080032	EUDAMED	Class IIa	Active
4 Channel Anorectal Balloon Catheter with Poly-Isoprene Balloon, 4.9mm	500049031	EUDAMED	Class IIa	Active
50cm Triple Lumen UPP Catheter, 9 CH	100090001	EUDAMED	Class IIa	Active
Pump Tube Set for MMS Libra and Solar Systems	400100005	EUDAMED	Class IIa	Active
4.5fg Rectal Catheter with PVC Balloon and Introducer	200045010	EUDAMED	Class IIa	Active
Bladder Filling Catheter, 6fg	100060015	EUDAMED	Class IIa	Active
Oracol Saliva Collection Device	S10	EUDAMEDFDA UDI	Class I	Active
Rectal Split Balloon Catheter with Introducer, 4.5fr	200045020	EUDAMED	Class IIa	Active
4 Lumen Anorectal Catheter with Distension Balloon	500049019	EUDAMED	Class IIa	Active
4.5fg Rectal Poly-Isoprene Balloon Catheter with Introducer	200045017	EUDAMED	Class IIa	Active
200cm Rectal PVC Balloon Catheter with Introducer, 4.5 CH	200045027	EUDAMED	Class IIa	Active
SondeAR - Air Charged Catheter	500060003	EUDAMED	Class IIa	Active
385mm Bladder Filling Catheter, 8 CH	100080001	EUDAMED	Class IIa	Active
8fg Double Lumen UPP Catheter with Y-Connector and Tiemann Tip	100080031	EUDAMED	Class IIa	Active
Set Guard	400100005	EUDAMED	Class IIa	Active
Bladder Filling Catheter, 8fg	100080014	EUDAMED	Class IIa	Active
8fg x 47cm Double Lumen Cystometry Catheter	100080015	EUDAMED	Class IIa	Active
2 Lumen Catheter for Cystometry, 6fr	100060007	EUDAMED	Class IIa	Active
Paediatric 8 Channel Single Use Water Perfused Anorectal Manometry Catheter with Poly-Isoprene Balloon, 3.9mm	500049065	EUDAMED	Class IIa	Active
Pump Tube Set (Laborie)	400120001	EUDAMED	Class IIa	Active
Double Lumen Cystometry Catheter, 6fr	100060008	EUDAMED	Class IIa	Active
8 Spirally Aligned Channels with Balloon, 3.9mm	500039034	EUDAMED	Class IIa	Active
4 channel anorectal manometry catheter with balloon 4.9mm	500049063	EUDAMED	Class IIa	Active
8 Channels for Radial Manometry Measurements, 3.9mm	500039025	EUDAMED	Class IIa	Active

Malvern Medical Developments Ltd also trading as PB Medical Ltd

What Malvern Medical Developments Ltd also trading as PB Medical Ltd makes

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