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eye-spec
EUDAMEDClass I (EU MDR)
Ref lin-gra-duo300Ref tech-blu225Ref lin-bla-duo100Ref lin-bla300Ref tech-gra300Ref poc-yel225Ref tech-bla275Ref poc-bluXL225Ref tech-yel250Ref tech-ora300Ref poc-blu125Ref wri-blu150Ref kreu-tor250Ref poc-yelXL250Ref lin-bla-duo300Ref poc-greyXL300Ref pod-cop-trio300Ref poc-yel200Ref tech-blu250Ref poc-yelXL175Ref poc-gra175Ref kreu-bla150Ref poc-yel150Ref poc-grey125Ref soho-gre150Ref poc-bla300Ref tech-yel125Ref soho-bla100Ref poc-grey275Ref poc-bla200Ref lin-gra100Ref poc-greyXL100Ref tech-gra275Ref poc-oraXL225Ref tech-grey275Ref poc-blaXL300Ref poc-pinXL100Ref lin-gra-duo150Ref pia-gra200Ref soho-gre300Ref poc-yel100Ref pod-cop200Ref poc-greyXL150Ref poc-ora250Ref poc-pinXL125Ref tech-yel200Ref kreu-gre150Ref poc-greyXL200Ref poc-bluXL150Ref poc-graXL150Ref poc-grey175
Identity
- Trade Name
- eye-spec EUDAMED
- Device Name
- Reading Glasses EUDAMED
- Model / Reference
- lin-gra-duo300 EUDAMEDtech-blu225 EUDAMEDlin-bla-duo100 EUDAMEDlin-bla300 EUDAMEDtech-gra300 EUDAMEDpoc-yel225 EUDAMEDtech-bla275 EUDAMEDpoc-bluXL225 EUDAMEDtech-yel250 EUDAMEDtech-ora300 EUDAMEDpoc-blu125 EUDAMEDwri-blu150 EUDAMEDkreu-tor250 EUDAMEDpoc-yelXL250 EUDAMEDlin-bla-duo300 EUDAMEDpoc-greyXL300 EUDAMEDpod-cop-trio300 EUDAMEDpoc-yel200 EUDAMEDtech-blu250 EUDAMEDpoc-yelXL175 EUDAMEDpoc-gra175 EUDAMEDkreu-bla150 EUDAMEDpoc-yel150 EUDAMEDpoc-grey125 EUDAMEDsoho-gre150 EUDAMEDpoc-bla300 EUDAMEDtech-yel125 EUDAMEDsoho-bla100 EUDAMEDpoc-grey275 EUDAMEDpoc-bla200 EUDAMEDlin-gra100 EUDAMEDpoc-greyXL100 EUDAMEDtech-gra275 EUDAMEDpoc-oraXL225 EUDAMEDtech-grey275 EUDAMEDpoc-blaXL300 EUDAMEDpoc-pinXL100 EUDAMEDlin-gra-duo150 EUDAMEDpia-gra200 EUDAMEDsoho-gre300 EUDAMEDpoc-yel100 EUDAMEDpod-cop200 EUDAMEDpoc-greyXL150 EUDAMEDpoc-ora250 EUDAMEDpoc-pinXL125 EUDAMEDtech-yel200 EUDAMEDkreu-gre150 EUDAMEDpoc-greyXL200 EUDAMEDpoc-bluXL150 EUDAMEDpoc-graXL150 EUDAMEDpoc-grey175 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060939040442 EUDAMED05060939042576 EUDAMED05060939040275 EUDAMED05060939040084 EUDAMED05060939042699 EUDAMED05060939041760 EUDAMED05060939042507 EUDAMED05060939041944 EUDAMED05060939043030 EUDAMED05060939042873 EUDAMED05060939041272 EUDAMED05060939041135 EUDAMED05060939040633 EUDAMED05060939042408 EUDAMED05060939040350 EUDAMED05060939042156 EUDAMED05060939043252 EUDAMED05060939041753 EUDAMED05060939042583 EUDAMED05060939042378 EUDAMED05060939041388 EUDAMED05060939040664 EUDAMED05060939041739 EUDAMED05060939041456 EUDAMED05060939040510 EUDAMED05060939041258 EUDAMED05060939042989 EUDAMED05060939040459 EUDAMED05060939041517 EUDAMED05060939041210 EUDAMED05060939040091 EUDAMED05060939042071 EUDAMED05060939042682 EUDAMED05060939042217 EUDAMED05060939042774 EUDAMED05060939041883 EUDAMED05060939042255 EUDAMED05060939040381 EUDAMED05060939041098 EUDAMED05060939040541 EUDAMED05060939041715 EUDAMED05060939043139 EUDAMED05060939042095 EUDAMED05060939041593 EUDAMED05060939042262 EUDAMED05060939043016 EUDAMED05060939040718 EUDAMED05060939042118 EUDAMED05060939041913 EUDAMED05060939042002 EUDAMED05060939041470 EUDAMED
- Basic UDI-DI
- 506093904EYESPEC01GE EUDAMED
- EMDN Code
- Q0210030201 READY TO WEAR METAL SPECTACLES WITH MINERAL LENSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
eye-spec by Out of Site 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506093904EYESPEC01GE | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Out of Site Ltd
- EUDAMED SRN
- UK-MF-000042912
- Authorised Representative
- SigmaTech Nordic ApS DK-AR-000039264
Sources (51)
- EUDAMED 0a1ea6a9-9b13-4842-ae6f-ab089140f2c6 61 fields · synced Oct 6, 2026
- EUDAMED 6e535050-ca58-49a1-96cd-44191dad309a 61 fields · synced May 11, 2026
- EUDAMED a9cef809-8ea7-4de7-98b8-456254be4cb0 61 fields · synced May 11, 2026
- EUDAMED dadd562a-d7d9-4d8b-97fb-bc66ddcd07b5 61 fields · synced May 11, 2026
- EUDAMED 14c2af27-62a4-4602-ab83-9d3713afa047 61 fields · synced May 11, 2026
- EUDAMED 1a8b6c4e-e1f5-452c-8ed0-2c1a4926a8f2 61 fields · synced May 11, 2026
- EUDAMED bb060611-9c84-4ee7-9ba7-c17768f3f51e 61 fields · synced May 16, 2026
- EUDAMED e5e07fe5-6731-4df3-8a28-60ce3fd71112 61 fields · synced May 16, 2026
- EUDAMED 50eabb3b-703e-49e2-b3ea-f36af483adc7 61 fields · synced May 16, 2026
- EUDAMED 3bfbd994-1d7c-4e40-a7c1-1dac329ce4a8 61 fields · synced May 16, 2026
- EUDAMED 54bd19ec-f5dc-4497-87c3-ea82d789cd9f 61 fields · synced May 16, 2026
- EUDAMED 3bcdb9b0-beb7-45fc-9541-6bd42b9f8604 61 fields · synced May 16, 2026
- EUDAMED 5b7bb84b-7e35-49b6-9d28-8ad6d6250858 61 fields · synced May 16, 2026
- EUDAMED b1f10936-f653-4680-87a7-030ee6ec3364 61 fields · synced May 16, 2026
- EUDAMED 5a1e85c4-75d9-45e6-a61d-22b37de37fdc 61 fields · synced May 16, 2026
- EUDAMED b9d95323-9aa9-4ab2-959a-1f4a131d4560 61 fields · synced May 16, 2026
- EUDAMED 6071e544-4701-42d8-b2d7-566231a93893 61 fields · synced May 16, 2026
- EUDAMED 2c2f53da-aa75-4035-a628-f64171657ef3 61 fields · synced May 16, 2026
- EUDAMED 2ecaef85-3f61-4de4-874d-8f7a14f4c184 61 fields · synced May 16, 2026
- EUDAMED d9cad8aa-7075-4999-98dc-f0e440b0fb04 61 fields · synced May 16, 2026
- EUDAMED 62167b74-e51c-479f-96d3-a72583f8160e 61 fields · synced May 16, 2026
- EUDAMED 788c5a35-c99c-402c-be82-2abdc52c19e7 61 fields · synced May 17, 2026
- EUDAMED a384c30a-655d-4357-acfe-2aed2f0fbe65 61 fields · synced May 17, 2026
- EUDAMED 79bf7fd0-3897-40e1-b30e-54b6df9d1454 61 fields · synced May 17, 2026
- EUDAMED 4cb9c539-8811-46d1-a227-fabafa962124 61 fields · synced May 17, 2026
- EUDAMED e98a9a24-876e-48f6-9682-ce21fe2c9cbe 61 fields · synced May 17, 2026
- EUDAMED 5f23e0ff-f8fa-41c8-a09b-30620bdf6a17 61 fields · synced May 17, 2026
- EUDAMED 7fd8d392-6dc7-4916-a1d8-4a8b1738605a 61 fields · synced May 17, 2026
- EUDAMED b9f13028-d5e8-4037-bcd5-4536dddf9e65 61 fields · synced May 17, 2026
- EUDAMED 3b9b3b47-355b-4746-a6df-364bf8958979 61 fields · synced May 17, 2026
- EUDAMED 21e3ce8e-6d8d-447b-be17-64347703296e 61 fields · synced May 17, 2026
- EUDAMED 4f1e229c-5623-43fd-86c5-6d3ca8618a58 61 fields · synced May 17, 2026
- EUDAMED 65e177d2-2afe-4ccd-a516-9aefd0fe6c17 61 fields · synced May 17, 2026
- EUDAMED 97618867-29e9-4682-b328-13b62971bdcd 61 fields · synced May 17, 2026
- EUDAMED 39ec292d-8cb5-47cf-9a7b-ec1ecc73979f 61 fields · synced May 17, 2026
- EUDAMED 07d5661a-184a-418b-8c24-9b5c7d0140ab 61 fields · synced May 17, 2026
- EUDAMED fdfe72c1-6bc9-4707-93e6-be06526378fe 61 fields · synced May 17, 2026
- EUDAMED 7510ac92-8cab-4f8a-9a60-fd3783bd8c16 61 fields · synced May 17, 2026
- EUDAMED f16dd275-7d89-44e7-be3b-605d46b114f1 61 fields · synced May 17, 2026
- EUDAMED 7b24471c-a823-48af-b82c-5d7e47c35d04 61 fields · synced May 17, 2026
- EUDAMED 1c4cb44a-da36-4e77-87b3-effeeb6dec82 61 fields · synced May 17, 2026
- EUDAMED a8af918a-0f7a-4ecc-ac9c-414cefc594b7 61 fields · synced May 17, 2026
- EUDAMED c28c23f3-54c4-42eb-9a68-6fb39b0ddd45 61 fields · synced May 17, 2026
- EUDAMED be092d46-6c18-4824-81d2-f4182713f147 61 fields · synced May 17, 2026
- EUDAMED 52f67a52-d4c5-46ed-ab70-6ccb5f632166 61 fields · synced May 17, 2026
- EUDAMED 3a2a5dac-352b-4884-afc8-b29c025f746c 61 fields · synced May 17, 2026
- EUDAMED e8c6612a-0d0e-41fe-96a0-b8e50b657e2d 61 fields · synced May 17, 2026
- EUDAMED 2c5d6d2b-7a10-4bd4-96cb-0bc064abc511 61 fields · synced May 17, 2026
- EUDAMED 68e454bd-1c00-40eb-9607-ae0e7099979c 61 fields · synced May 17, 2026
- EUDAMED 7667dc1f-f50e-4696-90fa-141285a5a967 61 fields · synced May 17, 2026
- EUDAMED 38ba93bd-b5ea-476b-b3f1-8981fefb6d37 61 fields · synced May 17, 2026