Question 1

What types of medical devices does Nantong Jianan Medical Products Co., Ltd. manufacture?

Accepted Answer

Nantong Jianan Medical Products Co., Ltd. specializes in wound care and protective medical textiles. Their product range includes sterile and non-sterile gauze swabs, gauze compresses, gauze bandages, gauze zigzag dressings, and non-woven isolation gowns. These items are designed for single-use applications in medical and clinical settings, addressing basic wound management and barrier protection needs.

Question 2

Where is Nantong Jianan Medical Products Co., Ltd. based?

Accepted Answer

The company is headquartered in China (CN). While the country of origin is relevant for regulatory tracking and supply chain transparency, it does not directly influence the classification or authorization status of their individual medical devices.

Question 3

Which regulatory registries list devices manufactured by Nantong Jianan Medical Products Co., Ltd.?

Accepted Answer

Devices from Nantong Jianan Medical Products Co., Ltd. are recorded in the EUDAMED database, which is the European Union’s medical device registry. This platform consolidates information on devices authorized under EU regulations, including their classification and manufacturer details, ensuring traceability and compliance tracking.

Question 4

How are devices from Nantong Jianan Medical Products Co., Ltd. classified under EU regulations?

Accepted Answer

The company’s devices are classified as Class I or Class IIa under EU medical device regulations. Gauze-based products (e.g., swabs, compresses, bandages) typically fall under Class I due to their low-risk profile for patient safety. In contrast, non-woven isolation gowns are classified as Class IIa, reflecting a slightly higher risk associated with their role in infection control and barrier protection. Classification determines regulatory requirements, such as conformity assessment procedures.

Device	Model / Reference	Registries	Class	Status
Cutting Gauze	C-SBQP-002	EUDAMED	Class I	Active
PBT Bandage	M030402010101	EUDAMED	Class I	Active
C-Sbbd-007	C-SBBD-007	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-004	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-017	EUDAMED	Class I	Active
Gauze Zigzag	C-SBPZ-003	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-002	EUDAMED	Class I	Active
Non-sterile Gauze Swab	C-FSBP-005	EUDAMED	Class I	Active
Gauze Zigzag	C-SBPZ-005	EUDAMED	Class I	Active
Elastic Bandage	C-TXBD-001	EUDAMED	Class I	Active
Medical Gauze Swab	100	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-005	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-014	EUDAMED	Class I	Active
Non-woven Swab	C-WFBP-002	EUDAMED	Class I	Active
Cotton Roll	C-YKM-002	EUDAMED	Class I	Active
Cotton Roll	C-YKM-001	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-008	EUDAMED	Class I	Active
Lap Sponges	901	EUDAMED	Class IIa	Active
Non-sterile Gauze Compresses	C-FSBD-006	EUDAMED	Class I	Active
Gauze Bandage	C-SBBD-009	EUDAMED	Class I	Active
Cotton Roll	CR-001	EUDAMED	Class I	Active
Disposable Surgical Face Mask	C-KZ-001	EUDAMED	Class I	Active
Sterile Gauze Swab	C-MJSBP-003	EUDAMED	Class I	Active

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