HomeChinaCHANGZHOU 3R MEDICAL DEVICE TECHNOLOGY CO.,LTD

CHANGZHOU 3R MEDICAL DEVICE TECHNOLOGY CO.,LTD

China · 常州 · www.czsryl.com
✓ Record-verifiedregistrations found in 3 marketsEU SRN CN-MF-000001123

This company holds 22 NMPA certificates in China and has registrations in European Union, United States — 2 overseas markets. EU UDI-DI records ≥294, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
22China registrations
Class I 9Class II 12Class III 1
as of 2026-09-04
EUEuropean UnionEUDAMED
≥294UDI-DI device records
Class IIa 213Class IIb 81
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
16listed device types
Class I 14Class II 1Class III 0unclassified 1
plus 16 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,103 raw hits, 6 excluded, 294 confirmed. Large result set — only the first 300 verified
United States16 registration records, 0 510(k), 0 PMA, 1 excluded
China22 certificates (Class III 1 / II 12 / I 9), as of 2026-09-04
United Kingdom0 confirmed, 1 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: CHANGZHOU 3R MEDICAL DEVICE TECHNOLOGY CO., LTD.

Regulatory identity

EU manufacturer SRN
CN-MF-000001123
EU authorised representative
Lotus NL B.V.
Exhibition record
CMEF 89th (Apr 2024, Shanghai)

Company information

Country
China
Social-insurance enrolees
25
Website
www.czsryl.com
Product categories
手术室及急救妇产及生殖消毒感控

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Registration status
Active
Incorporated
2012-04-16
Registered capital
CNY 5,000,000
Paid-in capital
CNY 5,000,000
Legal form
Limited liability company (natural-person invested or controlled)
Industry classification
Special-purpose equipment manufacturing
Last approval date
2023-12-27
Recognitions
Micro and small enterpriseNational High-Tech EnterpriseTechnology-based SME

Business registration data from Tianyancha, as of 2026-09-03. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA listed device types

showing 8 of 16
Cap, Surgical 1Forceps, Biopsy, Non-Electric 1Instrument, Ligature Passing And Knot Tying 1Container, Specimen Mailer And Storage, Sterile 1Dress, Surgical 1Accessory, Surgical Apparel 1Staple, Removable (Skin) 1Non-Surgical Gown 1

Registration details (sample)

MarketIdentifierNameClass / date
CN国械注准20233021207一次性使用结扎夹Class III
CN苏械注准20242021252一次性使用包皮切割手术器械包Class II
CN苏械注准20242021235腹腔镜用穿刺缝合器械包Class II
CN苏械注准20242021226一次性使用皮肤缝合器Class II
EU06977770463233Class IIa
EU06977770463240Class IIa
EU06977770463219Class IIa
EU06977770463202Class IIa

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