Question 1

What types of medical devices does GMD GROUP MEDİKAL SANAYİ produce?

Accepted Answer

GMD GROUP MEDİKAL SANAYİ specializes in manufacturing bioabsorbable sutures, specifically focusing on polyester sutures. These include monofilament and non-antimicrobial variants, such as polypropylenes and polydioxanone (PDO) sutures. Their products are designed for internal and external wound closure in surgical applications, with examples like DAMACRYL, DAMALENE, and DAMALON.

Question 2

Where is GMD GROUP MEDİKAL SANAYİ based?

Accepted Answer

The company is headquartered in Turkey, where it develops and produces its range of bioabsorbable sutures. This location is relevant for understanding regulatory compliance and manufacturing standards, particularly for devices intended for global markets.

Question 3

Which regulatory registries list GMD GROUP MEDİKAL SANAYİ’s devices?

Accepted Answer

GMD GROUP MEDİKAL SANAYİ’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices authorized for use within the EU, particularly important for Class III devices like their sutures.

Question 4

How are GMD GROUP MEDİKAL SANAYİ’s sutures classified under EU regulations?

Accepted Answer

GMD GROUP MEDİKAL SANAYİ’s sutures fall under EU Class III classification. This classification applies to high-risk devices, such as those used in wound closure where failure could cause severe harm. Class III devices require rigorous pre-market authorization and ongoing compliance to ensure safety and performance.

Device	Model / Reference	Registries	Class	Status
Damalon	DN2M30	EUDAMED	Class III	Active
Damalene	DE20HRT17-D-90	EUDAMED	Class III	Active
Damadioxanone	DX20HR40	EUDAMED	Class III	Active
Damacryl	DC1M40	EUDAMED	Class III	Active
Damalon	DN4K19-45	EUDAMED	Class III	Active
Polyamide	JN02DS40	EUDAMED	Class III	Active
Damalene	DE50DS12	EUDAMED	Class III	Active
Damalon	DN02K45	EUDAMED	Class III	Active
Damadioxanone	DX5M16	EUDAMED	Class III	Active
Damacryl	DC5K13	EUDAMED	Class III	Active
Damalene	DE1K45	EUDAMED	Class III	Active
Nylon	RN5K16	EUDAMED	Class III	Active
Damalene	DE50DR17-D	EUDAMED	Class III	Active
Polyamide	DRMPA40TC20-12	EUDAMED	Class III	Active
Damacryl	DC4K26U	EUDAMED	Class III	Active
Damalon	DN4M16	EUDAMED	Class III	Active
Damacryl	DC6K13	EUDAMED	Class III	Active
Damalene	DE50DR17-D-90	EUDAMED	Class III	Active
Damacryl	DC2M30	EUDAMED	Class III	Active
Polyamide	DRMPA50RC18-12	EUDAMED	Class III	Active
Damalon	DN5M17	EUDAMED	Class III	Active
Damacryl	DC0M35	EUDAMED	Class III	Active
Polyamide	JN1K40	EUDAMED	Class III	Active
Damacryl	DC0M40	EUDAMED	Class III	Active
Damacryl	DC2M19	EUDAMED	Class III	Active
Polypropylene	JE4M20-D	EUDAMED	Class III	Active
Damalene	DE50DS12-D	EUDAMED	Class III	Active
Damaester	DS02M40	EUDAMED	Class III	Active
Damalene	DE3K24	EUDAMED	Class III	Active
Damacryl	DC02M40	EUDAMED	Class III	Active
Damadioxanone	DX00HR40-100	EUDAMED	Class III	Active
Damalon	DN40DS24-45	EUDAMED	Class III	Active
Pdo	JX4M26	EUDAMED	Class III	Active
Damacryl	DC2M35	EUDAMED	Class III	Active
Polyamide	DRMPA50RC20-12	EUDAMED	Class III	Active
Damalon	DN60DS16-45	EUDAMED	Class III	Active
Polyester	JS00HR40G	EUDAMED	Class III	Active
Damaester	DS0M40	EUDAMED	Class III	Active
Damacryl	DC0M50	EUDAMED	Class III	Active
Damalene	DE1K36	EUDAMED	Class III	Active
Damacryl	DC3M26	EUDAMED	Class III	Active
Damalene	DE3K26	EUDAMED	Class III	Active
Polypropylene	JE02M50	EUDAMED	Class III	Active
Damalene	DE40DS22	EUDAMED	Class III	Active

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