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Counter Hip Brace

EUDAMED

Class I (EU MDR)

Ref 260001(L/Left/Black)Ref 260001(XL/Left/Black)Ref 260001(M/Right/Black)Ref 260001(S/Right/Black)Ref 260001(XL/Right/Black)Ref 260001(S/Left/Black)Ref 260001(M/Left/Black)

by Zhangpu Ortholife Rehabilitation Co., Ltd.

Identity

Trade Name
Counter Hip Brace EUDAMED
Device Name
Post-OP Brace (Hip orthosis) EUDAMED
Model / Reference
260001(L/Left/Black) EUDAMED
260001(XL/Left/Black) EUDAMED
260001(M/Right/Black) EUDAMED
260001(S/Right/Black) EUDAMED
260001(XL/Right/Black) EUDAMED
260001(S/Left/Black) EUDAMED
260001(M/Left/Black) EUDAMED

Identifiers

Primary DI / UDI-DI
04719872861577 EUDAMED
04719872861638 EUDAMED
04719872861607 EUDAMED
04719872861621 EUDAMED
04719872861645 EUDAMED
04719872861614 EUDAMED
04719872861591 EUDAMED
Basic UDI-DI
47198728626WJ EUDAMED
EMDN Code
Y061215 HIP ORTHOSES (INCLUDING ABDUCTION ORTHOSES) EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Netherlands EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Counter Hip Brace by Zhangpu Ortholife Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
CN-MF-000011447
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (7)

  • EUDAMED 3f50dd47-1e4a-453d-b309-ed144fa15c97 61 fields · synced Oct 6, 2026
  • EUDAMED 91efcb2d-9e79-4429-850a-bf5ff8d6307b 61 fields · synced May 16, 2026
  • EUDAMED b95c1eea-a74d-4b56-8f23-c0b1df6481ae 61 fields · synced May 17, 2026
  • EUDAMED 46c68cb6-0e93-41b1-9610-b08e7e9f49d5 61 fields · synced May 17, 2026
  • EUDAMED fb610dca-df3b-43c8-8bf4-26dc9cd28054 61 fields · synced May 17, 2026
  • EUDAMED 47c911ae-65bb-4987-82ac-e4ebb518fcc0 61 fields · synced May 18, 2026
  • EUDAMED 9e5a61a3-0171-4211-886e-75d20cb39cf4 61 fields · synced May 19, 2026