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Plastic Full Rim

EUDAMED

Class I (EU MDR)

Ref Plastic Optical FrameRef Metal Optical FrameRef SW0264-0Ref SW0142-0Ref R26248-0Ref R26405-0Ref SOEC101Ref SW0272-0Ref R26380-0Ref R26386-0Ref R26384-0Ref R26394-0Ref R26382-0Ref R26393-0Ref R26385-0Ref R26368-0Ref RMLOP27Ref R26392-0Ref SOEC100Ref R26377-0Ref SW0231-0Ref RMLOP26Ref R26383-0

by Wenzhou Sense Optical Co., Ltd.

Identity

Trade Name
Optical Frame EUDAMED
Device Name
Plastic Full Rim EUDAMED
Metal Half Rim EUDAMED
optical frame EUDAMED
Model / Reference
Plastic Optical Frame EUDAMED
Metal Optical Frame EUDAMED
SW0264-0 EUDAMED
SW0142-0 EUDAMED
R26248-0 EUDAMED
R26405-0 EUDAMED
SOEC101 EUDAMED
SW0272-0 EUDAMED
R26380-0 EUDAMED
R26386-0 EUDAMED
R26384-0 EUDAMED
R26394-0 EUDAMED
R26382-0 EUDAMED
R26393-0 EUDAMED
R26385-0 EUDAMED
R26368-0 EUDAMED
RMLOP27 EUDAMED
R26392-0 EUDAMED
SOEC100 EUDAMED
R26377-0 EUDAMED
SW0231-0 EUDAMED
RMLOP26 EUDAMED
R26383-0 EUDAMED

Identifiers

Primary DI / UDI-DI
06974600430014 EUDAMED
06974600430021 EUDAMED
06974600430083 EUDAMED
06974600430069 EUDAMED
06974600436948 EUDAMED
06974600430380 EUDAMED
06974600432964 EUDAMED
06974600439000 EUDAMED
06974600434036 EUDAMED
06974600432452 EUDAMED
06974600430366 EUDAMED
06974600430496 EUDAMED
06974600439161 EUDAMED
06974600431059 EUDAMED
06974600435873 EUDAMED
06974600436511 EUDAMED
06974600439970 EUDAMED
06974600433558 EUDAMED
06974600439345 EUDAMED
06974600433206 EUDAMED
06974600433350 EUDAMED
06974600437297 EUDAMED
06974600434616 EUDAMED
Basic UDI-DI
697460043FFPPZ EUDAMED
697460043FHMPZ EUDAMED
697460043152787 EUDAMED
69746004314267Y EUDAMED
EMDN Code
Q02100202 PLASTIC SPECTACLE FRAMES WITHOUT LENSES EUDAMED
Q02100201 METAL SPECTACLE FRAMES WITHOUT LENSES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Italy EUDAMED
Poland EUDAMED
Spain EUDAMED
Latvia 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

Plastic Full Rim by Wenzhou Sense Optical 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-000009540
Authorised Representative
Prolinx GmbH DE-AR-000005129

Sources (25)

  • EUDAMED 5166e186-d3cb-4f2b-b44c-ce0cd51704fd 61 fields · synced Oct 7, 2026
  • EUDAMED 0a40ec58-3b65-4b18-acb0-98abce37da30 61 fields · synced May 17, 2026
  • EUDAMED d071ed9e-75ae-4fde-bf8f-e93fa663fd27 61 fields · synced May 18, 2026
  • EUDAMED 8d8b62a9-6f9a-422f-8b0b-d6bcfaae9666 61 fields · synced May 18, 2026
  • EUDAMED 5fcebe4d-3746-4545-9c42-dd34831bc143 61 fields · synced Jun 18, 2026
  • EUDAMED 442b337f-0f49-4be6-ab8e-ab79c8dcefb3 61 fields · synced Jul 9, 2026
  • EUDAMED 7ed385fa-920d-4a27-ad56-a5c543fc73d1 61 fields · synced Jul 9, 2026
  • EUDAMED b0b07ed7-8cba-4d58-b6df-ad097031d02c 61 fields · synced Jul 10, 2026
  • EUDAMED 8a767f43-5605-4380-b2cb-03e9aa494644 61 fields · synced Jul 10, 2026
  • EUDAMED 95969301-8ce1-46a1-ac55-fc37de424465 61 fields · synced Jul 10, 2026
  • EUDAMED 8a07d115-35b7-464e-83d3-e06ca870286c 61 fields · synced Jul 11, 2026
  • EUDAMED 84575f1a-6ce4-4c8b-a170-576bbbc1094c 61 fields · synced Jul 11, 2026
  • EUDAMED 3b45a649-516c-4986-97c3-3feca8b029ff 61 fields · synced Jul 12, 2026
  • EUDAMED 2d78de84-798c-4b07-a49a-4b2a35764b32 61 fields · synced Jul 13, 2026
  • EUDAMED 93d7d9f6-878e-44c3-a449-d4815b2439ae 61 fields · synced Jul 15, 2026
  • EUDAMED 231fb541-895c-4b32-87e0-2857db6b5b1a 61 fields · synced Jul 18, 2026
  • EUDAMED efed0e2c-8e39-4529-98f1-99aa71f77498 61 fields · synced Jul 20, 2026
  • EUDAMED b240964c-55d8-4b5a-80a1-bc59f7582a60 61 fields · synced Jul 21, 2026
  • EUDAMED 35d4be29-4dc2-487d-aa60-d4f2cf553e9d 61 fields · synced Jul 22, 2026
  • EUDAMED 6fc30bb9-a89d-4078-95c0-4c0659f06719 61 fields · synced Jul 25, 2026
  • EUDAMED 60674013-2b43-44fd-b328-d2a4177a9421 61 fields · synced Jul 31, 2026
  • EUDAMED 80b5aaa2-9ab6-4e1e-bb18-dc6ad8c0df61 61 fields · synced Aug 1, 2026
  • EUDAMED b2c408a5-c20d-4a48-a5c1-207e9bdba939 61 fields · synced Aug 2, 2026
  • EUDAMED 41ede16c-3961-4bac-ae84-34d52078bd20 61 fields · synced Aug 2, 2026
  • EUDAMED 703c96b9-1bb1-42ff-b9ec-730df338402b 61 fields · synced Sep 17, 2026