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Roosin Medical Co., Ltd.

China·CN-MF-000021163

Last updated September 17, 2026

Information

Country: China
Address: No.8 Yuandong Road,Kouan Town, Gaogang, Taizhou, China
Website: www.roosin.net
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Wenhan Cheng
EUDAMED SRN: CN-MF-000021163
FDA FEI Number: 3007124979
DUNS Number: —

Catalogue (58)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Irrigation Solutions for Eye and Wound Washes	510.304002	EUDAMED	Class IIa	Active
Relistat+Nasal Wool Calcium Alginate Wound Dressing	2790	EUDAMED	Class IIb	Active
Cutiderm Super Absorbent Wound Dressing 10x10cm - Pack of 10	409.008001	EUDAMED	Class I	Active
Cutiderm Silicone Foam Dressing 15cm x15cm - Box of 5	412.011006	EUDAMED	Class IIb	Active
Cutiderm Silicone Foam Dressing 15cm x15cm - Pack of 1	412.011006	EUDAMED	Class IIb	Active
Cutiderm Silicone Foam Dressing 5cm x 5cm- Box of 10	412.011003	EUDAMED	Class IIb	Active
Relistat+Nasal Wool Calcium Alginate Wound Dressing	2790	EUDAMED	Class IIb	Active
Cutiderm Paraffin Gauze Dressing 5cm x 5cm - Box of 20	405.028002	EUDAMED	Class IIa	Active
Cutiderm Paraffin Gauze Dressing 7.5cm x 7.5cm - Box of 20	405.028004	EUDAMED	Class IIa	Active
Relistat+Nasal Wool Calcium Alginate Wound Dressing	2790	EUDAMED	Class IIb	Active
Sterile Burn Gel	403.001011	EUDAMED	Class IIb	Active
Irrigation Solutions for Eye and Wound Washes	510.309003	EUDAMED	Class IIa	Active
Cutiderm Paraffin Gauze Dressing 10cm x 10cm - Box of 10	405.028001	EUDAMED	Class IIa	Active
Paraffin Gauze Dressing	505.010005	EUDAMED	Class IIa	Active
Irrigation Solutions for Eye and Wound Washes	510.304002	EUDAMED	Class IIa	Active
Cutiderm Silicone Foam Dressing 5cm x 5cm- Pack of 1	412.011003	EUDAMED	Class IIb	Active
Hydrocolloid Wound Dressings	404.008005	EUDAMED	Class IIa	Active
Hydrocolloid Wound Dressings	404.008003	EUDAMED	Class IIa	Active
Burn Gel&Dressing Kit	BK001	EUDAMED	Class IIb	Active
405.028003	405.028003	EUDAMED	Class IIa	Active
Sterile Burn Gel	403.034002	EUDAMED	Class IIb	Active
Hydrocolloid Wound Dressings	404.008001	EUDAMED	Class IIa	Active
Copper Foam Dressing (Prescription and OTC)	K231088	FDA 510(k)	U	Active
Polyver Silver Alginate Dressing (Prescription and OTC)	K230190	FDA 510(k)	U	Active
Roosin Xeroform Petrolatum Dressing	K181478	FDA 510(k)	U	Active
Hydrophilic-Gel Exudate-Absorbent Dressings	402.046002	EUDAMED	Class IIb	Active
Paraffin gauze dressings	505.089002	EUDAMED	Class IIa	Active
Sterile hydrogel burn gel	BK003	EUDAMED	Class IIb	Active
Cotton Burn Dressings	405.068002	EUDAMED	Class IIa	Active
Sterile Burn Gels	403.034004	EUDAMED	Class IIb	Active
Cutiderm Hydrocolloid Extra Thin Wound Dressings 10x10cm - Box of 10	404.008002	EUDAMED	Class IIa	Active
Cotton Burn Dressings	405.028004	EUDAMED	Class IIa	Active
Sterile Burn Gel	403.001001	EUDAMED	Class IIb	Active
Sterile hydrogel burn dressing	BK002	EUDAMED	Class IIb	Active
Cutiderm	402.046001	EUDAMED	Class IIb	Active
Hydrocolloid Wound Dressings	404.008005	EUDAMED	Class IIa	Active
Foam Dressings	413.015002	EUDAMED	Class IIa	Active
Hydrocolloid Wound Dressings	404.008003	EUDAMED	Class IIa	Active
Sterile Burn Gel	403.056002	EUDAMED	Class IIb	Active
Cotton Burn Dressings	405.068005	EUDAMED	Class IIa	Active
Hydrocolloid Wound Dressings	83005	EUDAMED	Class IIa	Active
Hydrocolloid Wound Dressings	404.008004	EUDAMED	Class IIa	Active
Absorbent Pads	409.008001	EUDAMED	Class I	Active
Hydrocolloid Wound Dressings	404.008001	EUDAMED	Class IIa	Active
Hydrocolloid Wound Dressings	404.008006	EUDAMED	Class IIa	Active
Paraffin gauze dressings	505.089001	EUDAMED	Class IIa	Active
Cotton Burn Dressings	405.028001	EUDAMED	Class IIa	Active
Cotton Burn Dressings	405.068001	EUDAMED	Class IIa	Active
Calcium alginate wound dressings	402.021001	EUDAMED	Class IIb	Active
405.068003	405.068003	EUDAMED	Class IIa	Active

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Authorised Representatives

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Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Roosin Medical Co., Ltd. US