Question 1

What does Firstar Healthcare Company Limited (Guangzhou) make?

Accepted Answer

Firstar Healthcare Company Limited (Guangzhou) makes first aid kits that are non-medicated and single-use, as well as single-use cardiopulmonary resuscitation masks. These are the only device types specified in the provided data, and no other products, functions, or variations are mentioned or implied.

Question 2

Where is Firstar Healthcare Company Limited (Guangzhou) based?

Accepted Answer

Firstar Healthcare Company Limited (Guangzhou) is based in China, as explicitly stated in the SUMMARY section of the device data. The company’s location is identified by the country code CN and the full name includes Guangzhou, confirming its geographic base without reference to facilities, employee count, or operational scale.

Question 3

In which regulatory registries are Firstar Healthcare Company Limited (Guangzhou)'s devices listed?

Accepted Answer

The devices made by Firstar Healthcare Company Limited (Guangzhou) are listed in the Eudamed and FDA UDI registries, as stated in the LISTED IN field and repeated in the SUMMARY. This indicates that the devices have been entered into these two specific regulatory systems for identification and tracking, though this does not imply approval or clearance of the devices or the company.

Question 4

How are Firstar Healthcare Company Limited (Guangzhou)'s devices classified?

Accepted Answer

The devices made by Firstar Healthcare Company Limited (Guangzhou) are classified as Class I, Class II, Class IIa, and Class IIb, as explicitly listed in the DEVICE CLASSES field and confirmed in the SUMMARY. This range reflects varying risk levels under regulatory frameworks, but classification alone does not indicate authorization, approval, or clearance of any specific device.

Device	Model / Reference	Registries	Class	Status
First Aid Kit	1005	EUDAMED	Class IIb	Active
First Aid Kit	FS-094C	EUDAMED	Class I	Active
First Aid Kit	NH-FA-STD-01	EUDAMED	Class IIa	Active
First Aid Kit	NH-FA-REF-01	EUDAMED	Class I	Active
Firstar	FS-104	FDA UDI	Class II	Active
BrightCare	SQ1222	FDA UDI	Class I	Active
E+r	FS-103	FDA UDI	Class II	Unknown
Outerbanks	FS-9731	FDA UDI	Class I	Active
BrightCare	SQ1220	FDA UDI	Class I	Active
Firstar	4966	FDA UDI	Class II	Active
BrightCare	SQ1215	FDA UDI	Class I	Active
BrightCare	SQ1213	FDA UDI	Class I	Active
Firstar	4852	FDA UDI	Class II	Active
BrightCare	SQ1221	FDA UDI	Class I	Active
Micro Bird	A001998	FDA UDI	N/A	Active
Firstar	91018S74	FDA UDI	N/A	Active
Firstar	4852	FDA UDI	N/A	Active
Franklin	91018S74	FDA UDI	N/A	Active
Windy City Cabinet	WCC-001	FDA UDI	N/A	Active
Firstar	91018S74	FDA UDI	N/A	Active
BrightCare	SQ1212	FDA UDI	Class I	Active
BrightCare	SQ1214	FDA UDI	Class I	Active
First Aid Kit	BS-083B	EUDAMED	Class IIb	Active
First Aid Kit	SV2	EUDAMED	Class I	Active
First Aid Kit	FFS-005	EUDAMED	Class IIa	Active
First Aid Kit	32074645	EUDAMED	Class I	Active
First Aid Kit	FS-9020	EUDAMEDFDA UDI	Class IIa	Active
First Aid Kit	FS-059D	EUDAMED	Class I	Active
PLASTER DRESSING（Adhesive Plaster）	FS-195RA	EUDAMED	Class I	Active
First Aid Kit	FS-9740D	EUDAMED	Class I	Active
First Aid Kit	PL11065	EUDAMED	Class I	Active
First Aid Kit	G-01-003	EUDAMED	Class I	Active
First Aid Kit	FL-033	EUDAMED	Class IIa	Active
First Aid Kit	G-01-002	EUDAMED	Class I	Active
Outdoor First Aid Kit	MD-002	EUDAMED	Class I	Active
First Aid Kit	QT1121	EUDAMED	Class I	Active
First Aid Kit	FS-9740	EUDAMED	Class I	Active
First Aid Kit	PC-FMKIT	EUDAMED	Class IIa	Active
First Aid Kit	PC-TRKIT	EUDAMED	Class I	Active
Washproof Plasters Family Pack	PLAST11	EUDAMED	Class I	Active
Preparation Kit for Defibrillation	AB-023	EUDAMED	Class I	Active
First Aid Kit	0804601	EUDAMED	Class I	Active
AED Kit	AEDPK01	EUDAMED	Class I	Active
First Aid Kit	8510	EUDAMED	Class I	Active
First Aid Kit	PL12417	EUDAMED	Class I	Active
Plaster Strips	FS-195J	EUDAMED	Class I	Active
First Aid Kit	32034600 / 32034500 / 32034000	EUDAMED	Class I	Active
First Aid Kit	VT-008L	EUDAMED	Class IIa	Active
First Aid Kit	FS-RM001	EUDAMED	Class I	Active
First Aid Kit	KN-9042F	EUDAMED	Class IIb	Active

FIRSTAR HEALTHCARE COMPANY LIMITED (GUANGZHOU)

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