Question 1

What types of medical devices does Tynor Orthotics Pvt Ltd manufacture?

Accepted Answer

Tynor Orthotics Pvt Ltd specializes in manufacturing hamstring support devices. These products are designed as thigh-worn orthotics to provide compression, pain relief, and sweat absorption during physical activity or athletic exercises. The focus is on improving stability and reducing discomfort for users.

Question 2

Where is Tynor Orthotics Pvt Ltd based?

Accepted Answer

Tynor Orthotics Pvt Ltd is based in India. The company’s location influences its regulatory compliance and market reach, particularly for devices intended for international use.

Question 3

Which regulatory registries list Tynor Orthotics Pvt Ltd’s devices?

Accepted Answer

Tynor Orthotics Pvt Ltd’s devices are listed in the eudamed database, which is the EU’s central registry for medical devices. This registration is required for devices marketed within the European Economic Area (EEA) to demonstrate compliance with EU Medical Device Regulations.

Question 4

How are Tynor Orthotics Pvt Ltd’s devices classified under medical device regulations?

Accepted Answer

Tynor Orthotics Pvt Ltd’s devices fall under Class I classification. This classification is typically assigned to low-risk devices, such as compression garments or supportive orthotics, where the risk to the user is minimal. Class I devices generally require less stringent regulatory oversight compared to higher-risk categories.

Device	Model / Reference	Registries	Class	Status
Tynor	D 13	EUDAMED	Class I	Active
Tynor	B 02	EUDAMED	Class I	Active
Tynor	I 81	EUDAMED	Class I	Active
Tynor	E 10	EUDAMED	Class I	Active
Tynor	D 07	EUDAMED	Class I	Active
Tynor	L 21	EUDAMED	Class I	Active
Tynor	A 30	EUDAMED	Class I	Active
Tynor	E 01	EUDAMED	Class I	Active
Tynor	L 06	EUDAMED	Class I	Active
Tynor	E 48	EUDAMED	Class I	Active
Tynor	I 77	EUDAMED	Class I	Active
Tynor	D 09	EUDAMED	Class I	Active
Tynor	L 04	EUDAMED	Class I	Active
Tynor	D 01	EUDAMED	Class I	Active
Tynor	E 43	EUDAMED	Class I	Active
Tynor	L 03	EUDAMED	Class I	Active
Tynor	D 17	EUDAMED	Class I	Active
Tynor	A 16	EUDAMED	Class I	Active
Tynor	A 05	EUDAMED	Class I	Active
Tynor	H 22	EUDAMED	Class I	Active
Tynor	K 18	EUDAMED	Class I	Active
Tynor	D 43	EUDAMED	Class I	Active
Tynor	A 11	EUDAMED	Class I	Active
Tynor	A 11	EUDAMED	Class I	Active
Tynor	C 01	EUDAMED	Class I	Active
Tynor	I 66	EUDAMED	Class I	Active
Tynor	D 17	EUDAMED	Class I	Active
Tynor	E 43	EUDAMED	Class I	Active
Tynor	I 66	EUDAMED	Class I	Active
Tynor	L 02	EUDAMED	Class I	Active
Tynor	C 03	EUDAMED	Class I	Active
Tynor	I 01	EUDAMED	Class I	Active
Tynor	A 33	EUDAMED	Class I	Active
Tynor	B 03	EUDAMED	Class I	Active
Tynor	I 16	EUDAMED	Class I	Active
Tynor	A 33	EUDAMED	Class I	Active
Tynor	E 29	EUDAMED	Class I	Active
Tynor	J 06	EUDAMED	Class I	Active
Tynor	F 02	EUDAMED	Class I	Active
Tynor	B 07	EUDAMED	Class I	Active
Tynor	I 81	EUDAMED	Class I	Active
Tynor	D 13	EUDAMED	Class I	Active
Tynor	D 21	EUDAMED	Class I	Active
Tynor	F 03	EUDAMED	Class I	Active
Tynor	I 83	EUDAMED	Class I	Active
Tynor	L 04	EUDAMED	Class I	Active
Tynor	H 19	EUDAMED	Class I	Active
Tynor	A 03	EUDAMED	Class I	Active
Tynor	L 06	EUDAMED	Class I	Active
Tynor	D 25	EUDAMED	Class I	Active

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