Question 1

What types of devices does RFX+CARE Manufacturing Co., Ltd. produce?

Accepted Answer

RFX+CARE Manufacturing Co., Ltd. produces reusable compression and pressure socks or stockings, reusable waterproof bathing covers for casts or bandages, and pulmonary function analysis systems for adults. The company also manufactures various first aid kits and related components such as sterile bandages, adhesive plasters, and refill kits for first aid and ICM boxes.

The manufacturer's devices are classified as Class I and Class IIa and are listed in the EUDAMED registry. RFX+CARE Manufacturing Co., Ltd. is based in China (CN).

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is RFX+CARE Manufacturing Co., Ltd. based?

Accepted Answer

RFX+CARE Manufacturing Co., Ltd. is based in China, as indicated by the country code CN in the device data and confirmed in the summary section which states the manufacturer is located in China (CN).

Question 3

In which regulatory registry are RFX+CARE Manufacturing Co., Ltd.'s devices listed?

Accepted Answer

The devices manufactured by RFX+CARE Manufacturing Co., Ltd. are listed in the EUDAMED registry, as explicitly stated in both the LISTED IN field and the summary section of the provided device data.

Question 4

How are the devices made by RFX+CARE Manufacturing Co., Ltd. classified under regulatory rules?

Accepted Answer

The devices produced by RFX+CARE Manufacturing Co., Ltd. are classified as Class I and Class IIa, as directly specified in the DEVICE CLASSES field of the device data, meaning they fall into these two risk-based categories under the applicable regulatory framework.

Device	Model / Reference	Registries	Class	Status
Pansements doigts	050220	EUDAMED	Class I	Active
Burn Gel	FA200-9157	EUDAMED	Class IIa	Active
10x10cm Sterile Gauze swab	FA200-9170	EUDAMED	Class I	Active
Sterile Hydrocolloid dressing	FA200-9145	EUDAMED	Class IIa	Active
5x5cm Sterile Gauze swab	FA200-9168	EUDAMED	Class I	Active
Jula First Aid Cabinet Green	FA200-01017869	EUDAMED	Class IIa	Active
Careplus Folding FAK Medium	38334	EUDAMED	Class IIa	Active
Sterile wound dressing	FA200-9079	EUDAMED	Class I	Active
Sterile Adhesive Plaster	FA200-9025	EUDAMED	Class I	Active
Burn Gel	FA200-9153	EUDAMED	Class IIa	Active
Cleansing Wipe	FA200-9133	EUDAMED	Class IIa	Active
Pansements famille	050140	EUDAMED	Class I	Active
HeltiQ plaster foil Sensative	1200243	EUDAMED	Class I	Active
Kinesiology tape blue	4062731	EUDAMED	Class I	Active
Blister plaster	FA200-9115	EUDAMED	Class I	Active
Sterile Face Mask	FA200-9127	EUDAMED	Class I	Active
Sterile Bandage	FA200-9072	EUDAMED	Class I	Active
Graid Nordic Hardcase Pre-p L	700388	EUDAMED	Class IIa	Active
Sterile Bandage	FA200-9048	EUDAMED	Class I	Active
Blister plaster	FA200-9105	EUDAMED	Class I	Active
Kinesiology tape pink	4062729	EUDAMED	Class I	Active
Bande à découper multi-usages	925101	EUDAMED	Class I	Active
SOS Auto Bag Corp.	FA500-69001	EUDAMED	Class IIa	Active
Falck ice pack 300g	7169	EUDAMED	Class IIa	Active
RFX Allround FAK	FA200-557585	EUDAMED	Class IIa	Active
Sterile Adhesive Plaster	FA200-9039	EUDAMED	Class I	Active
Disposable Nitril gloves	556112R	EUDAMED	Class I	Active
Sterile Hydrocolloid dressing	FA200-9147	EUDAMED	Class IIa	Active
4business First aid dressing	45103	EUDAMED	Class I	Active
Blister plaster	FA200-9104	EUDAMED	Class I	Active
Boots Finger Bandage & Applicator	9208305	EUDAMED	Class I	Active
Heltiq Bandage towel	500519R	EUDAMED	Class I	Active
Cleansing Wipe	FA200-9164	EUDAMED	Class IIa	Active
5x7.5cm Sterile wound dressing((adhensive)	FA200-9181	EUDAMED	Class I	Active
Sterile wound dressing	FA200-9081	EUDAMED	Class I	Active
HeltiQ Cohesive bandage	311015R	EUDAMED	Class I	Active
Blister plaster	FA200-9120	EUDAMED	Class I	Active
Boots Skin closures	9208321	EUDAMED	Class I	Active
Refill Pla.in small white box	F2121	EUDAMED	Class IIa	Active
Normal Mykit Sport, Blue	FA500-562374	EUDAMED	Class IIa	Active
Burn Gel	FA200-9156	EUDAMED	Class IIa	Active
Blister plaster	FA200-9121	EUDAMED	Class I	Active
Bandes à découper Universelles	925256	EUDAMED	Class I	Active
Toddlers Standard box, Born	F2005	EUDAMED	Class IIa	Active
4business Wound compress	45110	EUDAMED	Class I	Active
Blister plaster	FA200-9109	EUDAMED	Class I	Active
Bande Cohésive	925258	EUDAMED	Class I	Active
5 x 5cm Sterile wound dressing((adhensive)	FA200-9178	EUDAMED	Class I	Active
pansements peau sensible	050133	EUDAMED	Class I	Active
Burn Gel	FA200-9154	EUDAMED	Class IIa	Active

RFX+CARE Manufacturing Co., Ltd.

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