Question 1

What types of medical devices does Cenefom Corp. manufacture?

Accepted Answer

Cenefom Corp. specializes in surgical medical devices, including tissue interface patches (like the STIP), haemostatic agents (such as HIMOSTA), wound care dressings (e.g., Anscare), and bipolar radiofrequency ablation systems (e.g., BTX Surg). These devices are primarily designed for minimally invasive procedures, wound management, and tissue sealing applications.

Question 2

Where is Cenefom Corp. based, and where are its devices listed?

Accepted Answer

Cenefom Corp. is based in Taiwan. Its devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for devices intended to be distributed within the European market under the Medical Device Regulation framework.

Question 3

How are the devices manufactured by Cenefom Corp. classified under EU regulations?

Accepted Answer

All devices produced by Cenefom Corp. fall under EU Class I classification. This classification is determined based on the risk associated with the device’s intended use and design, with Class I representing the lowest risk category in the EU’s medical device hierarchy.

Question 4

Are Cenefom Corp.’s devices intended for use outside the European market?

Accepted Answer

The provided information only confirms that Cenefom Corp.’s devices are registered in EUDAMED and classified under EU Class I, indicating compliance with the Medical Device Regulation (MDR) for distribution within the European Union. Whether these devices are also authorised or marketed in other regions (e.g., the US, Asia, or globally) is not specified in the available data.

Device	Model / Reference	Registries	Class	Status
Stip	AS 802015F	EUDAMED	Class I	Active
Himosta	NP-SL09S	EUDAMED	Class I	Active
Anscare	NS-013-2	EUDAMED	Class I	Active
Stip	AS 35126F	EUDAMED	Class I	Active
BTX Surg	WI0001Y	EUDAMED	Class I	Active
Stip	AS 803010F	EUDAMED	Class I	Active
Himosta	NP-LS15ST	EUDAMED	Class I	Active
Stip	AS 1002515	EUDAMED	Class I	Active
Stip	AS 1002515F	EUDAMED	Class I	Active
Himosta	NP-LL15	EUDAMED	Class I	Active
Anscare	NS-022-1	EUDAMED	Class I	Active
Himosta	NP-DL10S	EUDAMED	Class I	Active
Anscare	OS-011-1	EUDAMED	Class I	Active
Himosta	NP-LS10S	EUDAMED	Class I	Active
Anscare	NS-032-1	EUDAMED	Class I	Active
Himosta	NP-LS10S	EUDAMED	Class I	Active
Anscare	NS-011-1	EUDAMED	Class I	Active
Anscare	NS-017-2	EUDAMED	Class I	Active
Himosta	NP-LS15S	EUDAMED	Class I	Active
Himosta	NP-SL06S	EUDAMED	Class I	Active
Himosta	NP-LL15ST	EUDAMED	Class I	Active
Stip	AS 452015	EUDAMED	Class I	Active
Anscare	NS-012-1	EUDAMED	Class I	Active
Stip	AS 803015F	EUDAMED	Class I	Active
Stip	AS 452015F	EUDAMED	Class I	Active
Stip	AS 802010F	EUDAMED	Class I	Active
Himosta	NP-EL15S	EUDAMED	Class I	Active
Anscare	NS-015-1	EUDAMED	Class I	Active
Anscare	NS-041-1	EUDAMED	Class I	Active
Stip	AS 452010	EUDAMED	Class I	Active
Stip	AS 803015CF	EUDAMED	Class I	Active
Himosta	EP-0912	EUDAMED	Class I	Active
Stip	AS 452010F	EUDAMED	Class I	Active
Stip	AS 552515	EUDAMED	Class I	Active
Himosta	NP-ES15S	EUDAMED	Class I	Active
Himosta	NP-DL15S	EUDAMED	Class I	Active
Stip	AS 802015	EUDAMED	Class I	Active
Stip	AS 452015CF	EUDAMED	Class I	Active
Himosta	NP-LL15S	EUDAMED	Class I	Active
Anscare	NS-021-1	EUDAMED	Class I	Active
Anscare	NS-031-1	EUDAMED	Class I	Active
Stip	AS 35129F	EUDAMED	Class I	Active
Anscare	NS-014-1	EUDAMED	Class I	Active
Himosta	EP-0915	EUDAMED	Class I	Active
Anscare	NS-023-2	EUDAMED	Class I	Active
Stip	AS 802010	EUDAMED	Class I	Active
Cenefom	NP-EL10S	EUDAMED	Class I	Active
Cenefom	EP-0915F	EUDAMED	Class I	Active
Cenefom	NP-LS15W	EUDAMED	Class I	Active
Cenefom	OP-ES06	EUDAMED	Class I	Active

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