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
Non-sterile Gauze Compresses	C-FSBD-019	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-009	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-003	EUDAMED	Class I	Active
Gauze Bandage	C-SBBD-004	EUDAMED	Class I	Active
Sterile Gauze Swab	C-MJSBP-001	EUDAMED	Class I	Active
Non-sterile Gauze Swab	C-FSBP-004	EUDAMED	Class I	Active
Sterile Gauze Swab	C-MJSBP-007	EUDAMED	Class I	Active
Gauze Bandage	C-SBBD-006	EUDAMED	Class I	Active
Sterile Gauze Swab	C-MJSBP-008	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-023	EUDAMED	Class I	Active
Gauze Zigzag	C-SBPZ-004	EUDAMED	Class I	Active
Non-woven Isolation Gown	C-FHF-001	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-026	EUDAMED	Class I	Active
PBT Bandage	C-PBT-003	EUDAMED	Class I	Active
Non-woven Paper Tape	C-WFBZJD-001	EUDAMED	Class I	Active
Cotton Roll	C-YKM-003	EUDAMED	Class I	Active
Absorbent Gauze	C-SBPZ-014	EUDAMED	Class I	Active
Gauze Zigzag	C-SBPZ-001	EUDAMED	Class I	Active
Non-sterile Gauze Swab	C-FSBP-006	EUDAMED	Class I	Active
Silk Tape	C-SCJD-002	EUDAMED	Class I	Active
Cotton Roll	C-YKM-006	EUDAMED	Class I	Active
Gauze Bandage	C-SBBD-003	EUDAMED	Class I	Active
PBT Bandage	C-PBT-001	EUDAMED	Class I	Active
Zinc Oxide Plaster	C-YHX-004	EUDAMED	Class I	Active
Non-sterile Gauze Swab	C-FSBP-008	EUDAMED	Class I	Active
PBT Bandage	C-PBT-005	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-020	EUDAMED	Class I	Active
Silk Tape	C-SCJD-003	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-012	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-006	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-008	EUDAMED	Class I	Active
Non-sterile Gauze Swab	C-FSBP-007	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-024	EUDAMED	Class I	Active
Non-sterile Gauze Compresses	C-FSBD-016	EUDAMED	Class I	Active
Sterile Gauze Sponges	801	EUDAMED	Class I	Active
Non-woven Paper Tape	C-WFBZJD-002	EUDAMED	Class I	Active
Zinc Oxide Plaster	C-YHX-001	EUDAMED	Class I	Active
Cutting Gauze	C-SBQP-001	EUDAMED	Class I	Active
Cutting Gauze	C-SBQP-003	EUDAMED	Class I	Active
Sterile Gauze Swab	C-MJSBP-002	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-007	EUDAMED	Class I	Active
Bouffant Cap	C-WFBM-001	EUDAMED	Class I	Active
Medical Gauze Swab	C-WJSBP-001	EUDAMED	Class I	Active
Dental Cotton Roll	C-YKM-004	EUDAMED	Class I	Active
Silk Tape	C-SCJD-001	EUDAMED	Class I	Active
Kinesiology Tape	C-JNX-001	EUDAMED	Class I	Active
Non-sterile Gauze Swab	C-FSBP-001	EUDAMED	Class I	Active
Gauze Zigzag	C-SBPZ-007	EUDAMED	Class I	Active
Gauze Zigzag	C-SBPZ-010	EUDAMED	Class I	Active
Cutting Gauze	C-SBQP-004	EUDAMED	Class I	Active

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