Home›China›Zhang Pu Ortholife Rehabilitation Co., Ltd.

Zhang Pu Ortholife Rehabilitation Co., Ltd.

✓ Record-verifiedregistrations found in 7 marketsEU SRN CN-MF-000011447Unified social credit code 913506235959739786

This company holds 16 NMPA certificates in China and has registrations in European Union, United States, Brazil, Saudi Arabia, Taiwan, Israel — 6 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

16China registrations

Class I 16

as of 2026-09-04

EUEuropean UnionEUDAMED

≥300UDI-DI device records

Class I 300

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

21listed device types

Class I 21Class II 0Class III 0

plus 21 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

2registered devices

Class I 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 Union986 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

United States21 registration records, 0 510(k), 0 PMA

China16 certificates (Class III 0 / II 0 / I 16), as of 2026-09-04

Brazil2 confirmed, 0 excluded

Saudi Arabia3 confirmed, 1 excluded

Manufacturer names merged into this page: ZHANGPU ORTHOLIFE REHABILITATION CO., LTD · ZHANGPU ORTHOLIFE REHABILITATION CO.,LTD · Zhang Pu Ortholife Rehabilitation Co., Ltd

Regulatory identity

EU manufacturer SRN: CN-MF-000011447
EU authorised representative: SUNGO Europe B.V.
Unified social credit code: 913506235959739786
Exhibition record: Rehab & Elderly Care Expo (Spring 2026, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 87th (Spring 2023, Shanghai)

Business registration

Registration status: Active
Incorporated: 2012-06-05
Registered capital: USD 150,000
Paid-in capital: USD 150,000
Legal form: Limited liability company
Industry classification: Other manufacturing
Last approval date: 2021-04-07
Recognitions: Micro and small enterpriseAbove-designated-size industrial enterprise

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 21

Cushion, Flotation 1Sling, Arm, Overhead Supported 1Splint, Hand, And Components 1Orthosis, Limb Brace 1Orthosis, Truncal/Orthosis, Limb 1Joint, Hip, External Brace 1Orthosis, Corrective Shoe 1Joint, Knee, External Brace 1

Registration details (sample)

Market	Identifier	Name	Class / date
CN	闽漳械备20220009	下肢固定器	Class I
CN	闽漳械备20220008	躯干固定器	Class I
CN	闽漳械备20190023号	医用冰袋	Class I
CN	闽漳械备20190022号	康复训练器	Class I
EU	04719892931984	RPS T9 PRO	Class I
EU	04719892931977	RPS T9 PRO	Class I
EU	04719892931960	RPS T9 PRO	Class I
EU	04719892931953	RPS T9 PRO	Class I
BR	82411060015	Órteses de coluna	Class I
BR	80758210103	COLETE JEWETT	Class I
SA	ME0000012529SFDAA00001	FINGER SPLINT	—
SA	ME0000012529SFDAA00003	SPLINT WALKER	—

Zhang Pu Ortholife Rehabilitation Co., Ltd.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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