Question 1

What types of medical devices does Zhejiang Baite Medical Appliances Co., Ltd. primarily manufacture?

Accepted Answer

Zhejiang Baite Medical Appliances Co., Ltd. specializes in producing nasal oxygen cannulas designed for basic respiratory support. These devices are intended to deliver supplemental oxygen through the nostrils, helping patients with mild to moderate oxygen needs.

Question 2

Where is Zhejiang Baite Medical Appliances Co., Ltd. based?

Accepted Answer

The company is headquartered in China, specifically in Zhejiang Province. This geographical location influences its regulatory compliance and manufacturing operations, particularly for devices intended for global markets.

Question 3

Which regulatory registries list devices manufactured by Zhejiang Baite Medical Appliances Co., Ltd.?

Accepted Answer

The company’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry allows healthcare professionals, regulators, and patients to verify the presence of devices in the EU market.

Question 4

How are Zhejiang Baite Medical Appliances Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

The company’s nasal oxygen cannulas fall under Class I and Class IIa classifications in the EU. Class I devices are generally considered low-risk, while Class IIa devices involve a slightly higher risk and require additional conformity assessments, such as design controls and risk management.

Device	Model / Reference	Registries	Class	Status
Dct	H7 TC	EUDAMED	Class IIa	Active
Dct	F5 5255	EUDAMED	Class IIa	Active
Dct	H7 162	EUDAMED	Class IIa	Active
Dct	H7 1191	EUDAMED	Class IIa	Active
Dct	F5 0108	EUDAMED	Class IIa	Active
Dct	F5 0102	EUDAMED	Class IIa	Active
Dct	H7 0016	EUDAMED	Class IIa	Active
Dct	F5 0110	EUDAMED	Class IIa	Active
Dct	H7 1175	EUDAMED	Class IIa	Active
Dct	H7 161NT	EUDAMED	Class IIa	Active
Dct	H7 1495	EUDAMED	Class IIa	Active
Dct	F5 0107	EUDAMED	Class IIa	Active
Bm	BM0808	EUDAMED	Class IIa	Active
Bm	BM0618	EUDAMED	Class IIa	Active
Bm	BM0403	EUDAMED	Class IIa	Active
Bm	BM0621	EUDAMED	Class IIa	Active
Bm	BM1001	EUDAMED	Class I	Active
Bm	BM0507	EUDAMED	Class IIa	Active
Bm	BM0805	EUDAMED	Class IIa	Active
Bm	BM0407	EUDAMED	Class IIa	Active
Bm	BM0905	EUDAMED	Class IIa	Active
Bm	BM0608	EUDAMED	Class IIa	Active
Bm	BM0501	EUDAMED	Class IIa	Active
Bm	BM0510	EUDAMED	Class IIa	Active
Bm	BM0606	EUDAMED	Class IIa	Active
Bm	BM0804	EUDAMED	Class IIa	Active
Bm	BM0506	EUDAMED	Class IIa	Active
Bm	BM0624	EUDAMED	Class IIa	Active
Bm	BM1101	EUDAMED	Class I	Active
Bm	BM0619	EUDAMED	Class IIa	Active
Bm	BM0611	EUDAMED	Class IIa	Active
Bm	BM1107	EUDAMED	Class I	Active
Bm	BM0406	EUDAMED	Class IIa	Active
Bm	BM0603	EUDAMED	Class IIa	Active
Bm	BM0616	EUDAMED	Class IIa	Active
Bm	BM0806	EUDAMED	Class IIa	Active
Bm	BM0304	EUDAMED	Class IIa	Active
Bm	BM0623	EUDAMED	Class IIa	Active
Bm	BM0508	EUDAMED	Class IIa	Active
Bm	BM0908	EUDAMED	Class IIa	Active
Bm	BM0604	EUDAMED	Class IIa	Active
Bm	BM0617	EUDAMED	Class IIa	Active
Bm	BM0511	EUDAMED	Class IIa	Active
Bm	BM0408	EUDAMED	Class IIa	Active
Bm	BM1004	EUDAMED	Class I	Active
Bm	BM0405	EUDAMED	Class IIa	Active
Bm	BM0303	EUDAMED	Class IIa	Active
Bm	BM0504	EUDAMED	Class IIa	Active
Bm	BM1005	EUDAMED	Class I	Active
Bm	BM0301	EUDAMED	Class IIa	Active

ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.

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