Certifications & regulatory status
Three of SiLeap's platforms — DQ22, DQ30 and DQ58 — are NMPA Class II registered medical devices; the full range carries CPC and cytotoxicity-tested food-grade silicone tips. Every certificate below names its actual holder, and the registration is public: verify it yourself on the NMPA database.
NMPA Class II medical device registration
The strongest proof on this site, and the one you should not take our word for. The registration covers the complete medical package — device, box, IFU, materials — manufactured under a Class II production licence in the group's ISO 13485 facility.
- Registration number:
- 粤械注准 20262090588
- Covered models:
- DQ22 / DQ30 / DQ58
Two entities, honest attribution
A buyer who looks up the registration will see the registrant's name — so we say it first. Certificates on this site are held by two group entities, and each one is attributed to its actual holder:
Guangzhou SiLeap Medical Technology Co., Ltd
广州思跃医疗科技有限公司
Brand owner. Own dedicated workshop — builds the consumer line.
Guangzhou Aimei Intelligent Technology Co., Ltd
广州艾渼智能科技有限公司
Group ISO 13485 facility. Licensed manufacturer of the medical-registered line.
Why scope differs per certificate
Product certificates (CPC, FCC, RoHS, the cytotoxicity report) attach to the design — same hardware, same certificate, either line. Facility certificates (ISO 13485, the Class II production licence, the registration itself) attach to the line that builds the goods: they apply to the medical builds made in the licensed facility, and are never shown against consumer builds made in SiLeap's own workshop.
Certificate scope
Guangzhou SiLeap Medical Technology Co., Ltd
- Partial
CE
Product design · Consumer line · all models
- Complete
FCC
Product design · Consumer line · all models
- Complete
RoHS
Product design · Consumer line · DQ68
- Complete
CPC — Children's Product Certificate
Product design · Both lines · all models
- Complete
Silicone tip cytotoxicity report (C2511007-01)
Product design · Both lines · all models
Guangzhou Aimei Intelligent Technology Co., Ltd
- Complete
ISO 13485:2016
Production facility · Medical line · all models
- Complete
FDA registration (510(k) exempt)
Production facility · Medical line · DQ22 / DQ30 / DQ58
- Complete
CE (complete)
Product design · Medical line · all models
- Complete
FCC (complete)
Product design · Medical line · all models
- Complete
RoHS (complete)
Product design · Medical line · all models
- Complete
Class II Medical Device Production Licence
Production facility · Medical line · DQ22 / DQ30 / DQ58
- Complete
Class II Medical Device Registration Certificate
Production facility · Medical line · DQ22 / DQ30 / DQ58
Documents on file
Cover pages of the certificates and third-party test reports behind the claims above, each labelled with its issuer and holder. Full reports are shared with buyers during an RFQ, not published; the NMPA registration is verified by number, never as a PDF.
CE Verification of Conformity (EMC Directive)
EN IEC 55014-1:2021 / 55014-2:2021 · Issued by Waltek Testing Group · 2023-07
Held by AIMEI (group facility)
FCC Test Report (Pass)
47 CFR Part 15 Subpart B · Issued by Waltek Testing Group · 2023-07
Held by AIMEI (group facility)
RoHS Test Report
EU RoHS Directive · Issued by Waltek Testing Group · 2023-07
Held by AIMEI (group facility)
CPC / CPSIA Children's Product Test Report
16 CFR / ASTM F963-23 / CPSIA · Issued by AiT (Guangdong Asia Hongke) · 2024-12
Held by AIMEI (group facility)
Waterproof Test Report (Pass)
IEC 60529 (ingress protection) · Issued by Waltek Testing Group · 2023-10
Held by AIMEI (group facility)
Dust Ingress Test Report (Pass)
IEC 60529 (ingress protection) · Issued by Waltek Testing Group · 2023-08
Held by AIMEI (group facility)
CPC — US children's e-commerce
The Children's Product Certificate is held in SiLeap's own name and covers the full range. It is a mandatory upload for children's products on Amazon, Temu and Walmart US.
FDA status, stated precisely
The three medical-line models are FDA-registered as 510(k)-exempt devices — comparable to US Class I. This is a registration under exemption, not a 510(k) clearance.