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Upper Limb Brace(Elbow Orthosis)

EUDAMED

Class I (EU MDR)

Ref Elbow Orthosis-SModel XXS,XS,S,M,L,XL,XXL,XXXLRef Elbow Orthosis-XXXLRef Elbow Orthosis-LRef Elbow Orthosis-XXS

by AnPing HuaKang Medical Products Factory

Identity

Device Name
Upper Limb Brace(Elbow Orthosis) EUDAMED
Model / Reference
XXS,XS,S,M,L,XL,XXL,XXXL EUDAMED
Elbow Orthosis-S EUDAMED
Elbow Orthosis-XXXL EUDAMED
Elbow Orthosis-L EUDAMED
Elbow Orthosis-XXS EUDAMED

Identifiers

Primary DI / UDI-DI
06975813110427 EUDAMED
06975813110472 EUDAMED
06975813110441 EUDAMED
06975813110403 EUDAMED
Basic UDI-DI
697581311EO01JB EUDAMED
EMDN Code
Y060615 ELBOW ORTHOSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria 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

Upper Limb Brace(Elbow Orthosis) by Anping Huakang Medical Products Factory — 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

Manufacturer
AnPing HuaKang Medical Products Factory
EUDAMED SRN
CN-MF-000036122
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (4)

  • EUDAMED b2da96e8-4b9b-4183-8f9a-833b6853dab7 61 fields · synced Jul 31, 2026
  • EUDAMED fafd0e31-f242-4ab3-8559-5411bc88fef7 61 fields · synced May 18, 2026
  • EUDAMED 64c3214d-1702-4ffa-821a-3d79aadb4484 61 fields · synced May 18, 2026
  • EUDAMED 696d29d0-f13b-4e62-aee5-9d70e59bb5f1 61 fields · synced May 18, 2026