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	FS-RM001	EUDAMED	Class I	Active
First Aid Kit	KN-9042F	EUDAMED	Class IIb	Active
CPR Face Shield	110109	EUDAMED	Class I	Active
First Aid Kit	T32313-0001	EUDAMED	Class I	Active
First Aid Kit	VT-008S	EUDAMED	Class IIa	Active
First Aid Kit	EA9932	EUDAMED	Class IIa	Active
First Aid Kit	FS-018D	EUDAMED	Class I	Active
First Aid Kit	210669	EUDAMED	Class I	Active
First Aid Kit	PL11067	EUDAMED	Class IIa	Active
First Aid Kit	FS-110.	EUDAMED	Class I	Active
First Aid Kit	0804631	EUDAMED	Class IIa	Active
First Aid Kit	KL-10033/KL-10034	EUDAMED	Class IIb	Active
First Aid Kit	0804602	EUDAMED	Class I	Active
First Aid Kit	AD-048L	EUDAMED	Class IIa	Active
First Aid Kit	PC-9706F	EUDAMED	Class I	Active
First Aid Kit	KL-10043/KL-10044	EUDAMED	Class IIb	Active
First Aid Kit	OXY-9020V	EUDAMED	Class I	Active
First Aid Kit	LF-271B	EUDAMED	Class IIa	Active
First Aid Kit	H1221	EUDAMED	Class I	Active
First Aid Kit	OXY-9020S	EUDAMED	Class I	Active
First Aid Kit	FS-011	EUDAMED	Class IIa	Active
Medium First Aid Compact	KL-10030/KL-10031/KL-10032	EUDAMED	Class I	Active
First Aid Kit	PL11066	EUDAMED	Class I	Active
First Aid Kit	0804622	EUDAMED	Class I	Active
First Aid Kit	652871	EUDAMED	Class I	Active
Assorted Fabric Plasters Family Pack	PLAST12	EUDAMED	Class I	Active
First Aid Kit	H1220	EUDAMED	Class I	Active
First Aid Kit	LT90314	EUDAMED	Class I	Active
First Aid Bag Compack	FFS-9062R	EUDAMED	Class I	Active
First Aid Kit	652870	EUDAMED	Class IIb	Active
First Aid Kit	8502	EUDAMED	Class I	Active
First Aid Kit	200202	EUDAMED	Class I	Active
First Aid Kit	0804600	EUDAMED	Class I	Active
First Aid Kit	FS-008D	EUDAMED	Class I	Active
First Aid Kit	0804605	EUDAMED	Class I	Active
First Aid Kit	OUC-M	EUDAMED	Class IIb	Active
First Aid Kit	4444-2000	EUDAMED	Class I	Active
First Aid Kit	PC-TRKIT	EUDAMED	Class I	Active
Soft Kit Compact	KL-10040/KL-10041/KL-10042	EUDAMED	Class I	Active
First Aid Kit	FS-048	EUDAMED	Class I	Active
First Aid Kit	KL-10020/KL-10021/KL-10022	EUDAMED	Class IIa	Active
First Aid Kit	180036	EUDAMED	Class I	Active
First Aid Kit	PL12418	EUDAMED	Class IIb	Active
Plaster Dressing	FS-195RB	EUDAMED	Class I	Active
First Aid Kit	PC-9708F	EUDAMED	Class I	Active
First Aid Kit	LT90311	EUDAMED	Class I	Active
First Aid Kit	701420	EUDAMED	Class I	Active
First Aid Kit	9737	EUDAMED	Class I	Active
First Aid Kit	FS-094S	EUDAMED	Class I	Active
First Aid Kit	PO-055	EUDAMED	Class I	Active

FIRSTAR HEALTHCARE COMPANY LIMITED (GUANGZHOU)

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