Question 1

What types of medical devices does DTR Medical Ltd manufacture?

Accepted Answer

DTR Medical Ltd produces a range of reusable and single-use medical instruments primarily for surgical and diagnostic procedures. These include suction handles (with and without suction control), aspiration cannulae, forceps (such as mosquito forceps), specula (including ear specula in various shapes and sizes), and specialized tools like Cusco specula and laryngeal suction devices. The designs vary by size, bend angle, and material to meet specific clinical needs in otolaryngology, general surgery, and endoscopic applications.

Question 2

Where is DTR Medical Ltd based, and how does this affect its devices?

Accepted Answer

DTR Medical Ltd is based in the United Kingdom. As a UK-based manufacturer, its devices must comply with EU medical device regulations if marketed within the European Union. The company’s products are registered in EUDAMED, the EU’s public database for medical devices, ensuring transparency and traceability for regulatory oversight.

Question 3

How are DTR Medical Ltd’s devices classified under EU regulations?

Accepted Answer

DTR Medical Ltd’s devices are classified as Class I or Class IIa under EU medical device regulations. The classification depends on factors like risk level, intended use, and potential harm to patients. For example, simple instruments like ear specula are typically Class I, while more specialized tools (e.g., suction devices with complex functions) may fall under Class IIa due to higher risk or critical applications. This classification determines the regulatory scrutiny and documentation requirements for each device.

Question 4

Are DTR Medical Ltd’s devices listed in any regulatory registries, and why does this matter?

Accepted Answer

Yes, DTR Medical Ltd’s devices are listed in EUDAMED, the European Union’s medical device registry. This registry provides public access to information about devices placed on the EU market, including manufacturer details, device identifiers, and regulatory status. Listing in EUDAMED ensures compliance with EU Medical Device Regulations (MDR) and helps healthcare professionals, regulators, and patients verify the legitimacy and traceability of the devices.

Question 5

What are some examples of DTR Medical Ltd’s most common device types, and what are they used for?

Accepted Answer

DTR Medical Ltd’s portfolio includes suction handles (e.g., Frazier suction with adjustable bends for airway management), aspiration cannulae (angled or straight for fluid removal), ear specula (single-use or reusable for otoscopic exams), and forceps (e.g., mosquito forceps for delicate tissue handling). Devices like Cusco specula are used in endoscopic procedures, while laryngeal suction tools assist in airway clearance. The variations in size, bend angles, and materials cater to specific clinical needs across otolaryngology, surgery, and endoscopy.

Device	Model / Reference	Registries	Class	Status
Oral Rotating Biopsy Punch 120 mm	OBRSAMPLE-3	EUDAMED	Class IIa	Active
Oesophageal/ Laryngeal 2mm x 215mm, 30° angle, proximal bend with suction control hole	74-2030	EUDAMEDFDA UDI	Class IIa	Active
Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction control hole	74-2012	EUDAMEDFDA UDI	Class IIa	Active
Frazier Suction Handle 204 x 2mm OD (6Fg), straight, Cross fenestrated	FSF2046	EUDAMEDFDA UDI	Class IIa	Active
Cusco Specula Insulated with Smoke Tube Large Extra Long	CSI100LE	EUDAMEDFDA UDI	Class I	Active
McIndoe Dissecting Forceps 150mm non toothed	MDF5001-D	EUDAMED	Class IIa	Active
FESS Sinus suction tube, 3mm x 85mm, distal bend, 80° angle with olive tip c/w control hole	74-2060	EUDAMEDFDA UDI	Class IIa	Active
Single-use Rosen Round Ear Specula 6mm, non sterile	ESP1006	EUDAMED	Class I	Active
Frazier Lampert type, 2mm x 125mm, proximal bend with suction control hole	74-2017	EUDAMEDFDA UDI	Class IIa	Active
Sinus Suction Handle 12Fg 90 degrees	SSH2912	EUDAMED	Class IIa	Active
Single-use Shea Ear Specula Size 3 (5.5mm x 7.5mm) non sterile	SSP1003	EUDAMED	Class I	Active
Single-use Rosen Round Ear Specula 3mm, non sterile	ESP1003	EUDAMED	Class I	Active
Frazier Suction Handle 200 x 3mm OD (9Fg), straight, fenestrated	FSF2009	EUDAMEDFDA UDI	Class IIa	Active
Adson Toothed Forceps 120mm	ATS5001-S	EUDAMED	Class IIa	Active
Frazier Suction Handle 200 x 2mm OD (6Fg), straight, fenestrated	FSF2006	EUDAMEDFDA UDI	Class IIa	Active
Single-use Rosen Round Ear Specula 5mm, non sterile	ESP1005	EUDAMED	Class I	Active
Oesophageal/ Laryngeal 4mm x 165mm, 30° angle, proximal bend with suction control hole	74-2080	EUDAMEDFDA UDI	Class IIa	Active
Crocodile Micro Forceps, black finish	CFB2001-S	EUDAMEDFDA UDI	Class IIa	Active
Single-use Oval Ear Specula size 4 (6.0mm) non sterile	OSP1004	EUDAMED	Class I	Active
Cusco Specula Metal Large Long	CMM100LL	EUDAMED	Class I	Active
Aspiration Cannulae 100mm Angled, 3.0mm/11G	74-1297	EUDAMEDFDA UDI	Class IIa	Active
Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, with suction control hole	74-2013	EUDAMEDFDA UDI	Class IIa	Active
Spencer Wells Artery Forceps 185mm straight	SWF2018	EUDAMED	Class IIa	Active
Silicone Tubing	SM525	EUDAMED	Class I	Active
Aspiration Cannulae 70mm Angled, 1.2mm/18G	74-1232	EUDAMEDFDA UDI	Class IIa	Active
Oral Rotating Biopsy Punch Long 180 mm	OBRLSAMPLE-3	EUDAMED	Class IIa	Active
Adson Forceps 1x2 with plateau 150mm	ATP2015-D	EUDAMED	Class IIa	Active
Spencer Wells Artery Forceps 155mm straight	SWF2015	EUDAMED	Class IIa	Active
Tip Shields	SM3040	EUDAMED	Class I	Active
Cusco Specula Insulated with Smoke Tube Medium	CSI200M	EUDAMEDFDA UDI	Class I	Active
Ormerod Forceps, black finish	OFB1001-S	EUDAMED	Class IIa	Active
Sinus Suction Handle 9Fg 90 degrees	SSH2909	EUDAMED	Class IIa	Active
Crocodile Fine Jaw Micro Forceps, black finish	CFBF2001-S	EUDAMEDFDA UDI	Class IIa	Active
Kocher Artery Forceps 140mm	KAF2014-D	EUDAMED	Class IIa	Active
Adson Forceps 1x2 with plateau 120mm	ATP2012-D	EUDAMED	Class IIa	Active
Frazier Suction Handle 2.66mm OD (8fg) 150° bend	FSH2008-B	EUDAMEDFDA UDI	Class IIa	Active
Frazier Suction Handle 204 x 2.66mm OD (8Fg), straight, Cross fenestrated	FSF2048	EUDAMEDFDA UDI	Class IIa	Active
Oesophageal/ Laryngeal 4mm x 350mm, 30° angle, proximal bend with suction control hole	74-2087	EUDAMEDFDA UDI	Class IIa	Active
Frazier Lampert Type 3mm x 125mm, proximal bend, with suction control hole	74-2050	EUDAMEDFDA UDI	Class IIa	Active
Zoellner Pen grip type, 2mm x 100mm, medial bend acute 30 degree angle, without control hole	74-2016P	EUDAMEDFDA UDI	Class IIa	Active
Oesophageal/ Laryngeal 4mm x 215mm, 30° angle, proximal bend with suction control hole	74-2082	EUDAMEDFDA UDI	Class IIa	Active
Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction control hole	74-2011	EUDAMEDFDA UDI	Class IIa	Active
Aspiration Cannulae 70mm Angled, 0.9mm/20g	74-1233	EUDAMEDFDA UDI	Class IIa	Active
Oral Biopsy Forceps 90mm	OBF1001-S	EUDAMED	Class IIa	Active
Henckel Aural Forceps	HAF1001-D	EUDAMED	Class IIa	Active
Frazier Suction Handle 204 x 4mm OD (12Fg)	FSH2012	EUDAMEDFDA UDI	Class IIa	Active
Fine Suture Forceps, Serrated 105mm	SSF2001-S	EUDAMED	Class IIa	Active
FESS Sinus suction tube, 3mm x 85mm, distal bend, 65° angle with olive tip c/w control hole	74-2063	EUDAMEDFDA UDI	Class IIa	Active
Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, with suction control hole	74-2014P	EUDAMEDFDA UDI	Class IIa	Active
Aspiration Cannulae 80mm Angled, 1.7mm/15G	74-1265	EUDAMEDFDA UDI	Class IIa	Active

DTR MEDICAL LTD

What DTR MEDICAL LTD makes

Frequently asked questions

Information

Catalogue (150)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities

FDA Establishments (1)