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Solojekt
EUDAMEDClass IIa (EU MDR)
Ref IT-03-14-LLModel SOLOJEKTRef IT-14-38-00Ref IT-05-13-LLRef IT-05-24-LLRef IT-03-23-LSRef IT-10-22-LLRef IT-03-22-LLRef IT-05-26-LLRef IT-10-12-LLRef IT-17-27-LSRef IT-05-18-LLRef IT-11-00-CTRef IT-05-19-LSRef IT-07-22-LSRef IT-13-39-00Ref IT-07-23-LSRef IT-20-46-00Ref IT-17-24-LSRef IT-03-13-LLRef IT-17-32-LSRef IT-20-52-00Ref IT-17-27-LLRef IT-05-00-LLRef IT-03-24-LSRef IT-14-37-00Ref IT-09-14-LSRef IT-20-49-00Ref IT-10-18-LLRef IT-17-30-LLRef IT-20-55-00Ref IT-20-47-00Ref IT-07-13-LSRef IT-07-26-LSRef IT-12-36-00Ref IT-17-26-LSRef IT-15-36-00Ref IT-07-18-LLRef IT-12-37-00Ref IT-05-14-LLRef IT-20-51-00Ref IT-07-14-LSRef IT-17-29-LLRef IT-13-35-00Ref IT-20-56-00Ref IT-03-23-LLRef IT-10-19-LLRef IT-10-20-LLRef IT-17-31-LSRef IT-07-21-LLRef IT-09-20-LLRef IT-20-43-00
Identity
- Trade Name
- SOLOJEKT EUDAMED
- Device Name
- HYPODERMIC SYRINGE EUDAMEDSTERILE INSULIN SYRINGE EUDAMEDHYPODERMIC SYRINGE WITHOUT NEEDLE EUDAMED
- Model / Reference
- SOLOJEKT EUDAMEDIT-03-14-LL EUDAMEDIT-14-38-00 EUDAMEDIT-05-13-LL EUDAMEDIT-05-24-LL EUDAMEDIT-03-23-LS EUDAMEDIT-10-22-LL EUDAMEDIT-03-22-LL EUDAMEDIT-05-26-LL EUDAMEDIT-10-12-LL EUDAMEDIT-17-27-LS EUDAMEDIT-05-18-LL EUDAMEDIT-11-00-CT EUDAMEDIT-05-19-LS EUDAMEDIT-07-22-LS EUDAMEDIT-13-39-00 EUDAMEDIT-07-23-LS EUDAMEDIT-20-46-00 EUDAMEDIT-17-24-LS EUDAMEDIT-03-13-LL EUDAMEDIT-17-32-LS EUDAMEDIT-20-52-00 EUDAMEDIT-17-27-LL EUDAMEDIT-05-00-LL EUDAMEDIT-03-24-LS EUDAMEDIT-14-37-00 EUDAMEDIT-09-14-LS EUDAMEDIT-20-49-00 EUDAMEDIT-10-18-LL EUDAMEDIT-17-30-LL EUDAMEDIT-20-55-00 EUDAMEDIT-20-47-00 EUDAMEDIT-07-13-LS EUDAMEDIT-07-26-LS EUDAMEDIT-12-36-00 EUDAMEDIT-17-26-LS EUDAMEDIT-15-36-00 EUDAMEDIT-07-18-LL EUDAMEDIT-12-37-00 EUDAMEDIT-05-14-LL EUDAMEDIT-20-51-00 EUDAMEDIT-07-14-LS EUDAMEDIT-17-29-LL EUDAMEDIT-13-35-00 EUDAMEDIT-20-56-00 EUDAMEDIT-03-23-LL EUDAMEDIT-10-19-LL EUDAMEDIT-10-20-LL EUDAMEDIT-17-31-LS EUDAMEDIT-07-21-LL EUDAMEDIT-09-20-LL EUDAMEDIT-20-43-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06118002221485 EUDAMED06118002224233 EUDAMED06118002221720 EUDAMED06118002221805 EUDAMED06118002221423 EUDAMED06118002222352 EUDAMED06118002221539 EUDAMED06118002221829 EUDAMED06118002222284 EUDAMED06118002222406 EUDAMED06118002221744 EUDAMED06118002224110 EUDAMED06118002221638 EUDAMED06118002221911 EUDAMED06118002224202 EUDAMED06118002221928 EUDAMED06118002224332 EUDAMED06118002222376 EUDAMED06118002221478 EUDAMED06118002222451 EUDAMED06118002224394 EUDAMED06118002222499 EUDAMED06118002221836 EUDAMED06118002221430 EUDAMED06118002224226 EUDAMED06118002222116 EUDAMED06118002224363 EUDAMED06118002222314 EUDAMED06118002222529 EUDAMED06118002224424 EUDAMED06118002224349 EUDAMED06118002221850 EUDAMED06118002221959 EUDAMED06118002224127 EUDAMED06118002222390 EUDAMED06118002224264 EUDAMED06118002221997 EUDAMED06118002224134 EUDAMED06118002221737 EUDAMED06118002224387 EUDAMED06118002221867 EUDAMED06118002222512 EUDAMED06118002224165 EUDAMED06118002224431 EUDAMED06118002221546 EUDAMED06118002222321 EUDAMED06118002222338 EUDAMED06118002222444 EUDAMED06118002222024 EUDAMED06118002222239 EUDAMED06118002224301 EUDAMED
- Basic UDI-DI
- 611800222HYPOSRGGD EUDAMED611800222SYRINSBL EUDAMED611800222HYPSYRWO2A EUDAMED
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMEDA02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMEDA02010203 INFUSION AND IRRIGATION SYRINGES, CATHETER CONE, SINGLE-USE EUDAMEDA0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Solojekt by I'M Medicare SARL — Class IIa — 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 | 611800222HYPOSRGGD | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- I'M Medicare SARL
- EUDAMED SRN
- MA-MF-000037665
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (51)
- EUDAMED 17f957a7-e33c-4af1-be51-dacda1274460 61 fields · synced Oct 6, 2026
- EUDAMED 169531f7-67f3-4347-8ee8-4ab52f7c07dc 61 fields · synced May 11, 2026
- EUDAMED 320ac002-74e3-44e1-b347-1f83e2e1c2ac 61 fields · synced May 16, 2026
- EUDAMED f7d8281a-11b1-4e60-bc52-a4df741e0699 61 fields · synced May 16, 2026
- EUDAMED 73ce8941-d36b-4dd3-87e3-eff4ec722309 61 fields · synced May 16, 2026
- EUDAMED 7eefa9c4-7d9b-40aa-8cc2-a0ec2ffe33bb 61 fields · synced May 16, 2026
- EUDAMED 6d3de853-3855-412c-80cd-d22c9b42d9a3 61 fields · synced May 16, 2026
- EUDAMED ae347537-61e4-4cbe-b888-65aee899c111 61 fields · synced May 16, 2026
- EUDAMED 36f8e702-1355-45f8-a98c-03a99ea80115 61 fields · synced May 16, 2026
- EUDAMED f000ade6-bc7a-4e3c-8021-3575cf0c89f8 61 fields · synced May 16, 2026
- EUDAMED ac9e039c-5d40-487d-829b-71760d2b5740 61 fields · synced May 16, 2026
- EUDAMED 5409749b-1fb8-4c05-abe8-636d8f9df0a8 61 fields · synced May 16, 2026
- EUDAMED e045ba49-227d-4ce3-a340-3e89a6368ad9 61 fields · synced May 16, 2026
- EUDAMED 762aeb4e-51ca-491e-9231-c02e2cc53682 61 fields · synced May 16, 2026
- EUDAMED 30f290ef-73d8-4d0d-a517-63fab5d4beaf 61 fields · synced May 17, 2026
- EUDAMED ad985083-8ddc-47bb-8ffd-39ca9e9c34aa 61 fields · synced May 17, 2026
- EUDAMED b5a849c8-23ca-48e3-b169-ec7c086b97ae 61 fields · synced May 17, 2026
- EUDAMED f3579a53-d29b-4489-aff9-f09df6aaed96 61 fields · synced May 17, 2026
- EUDAMED 12bd3c33-f175-435e-95ad-5b5930ccd070 61 fields · synced May 17, 2026
- EUDAMED 78b93ac2-f29a-4a0f-bc30-28332ab0f043 61 fields · synced May 17, 2026
- EUDAMED c93ccbef-fdab-411b-b879-35e071a58d83 61 fields · synced May 17, 2026
- EUDAMED 5d5d2a10-0f85-4fb8-9f6c-a3cd68071782 61 fields · synced May 17, 2026
- EUDAMED eb3d232f-9b46-4ea2-91b9-eb320b893b63 61 fields · synced May 17, 2026
- EUDAMED 0dc42ef6-cc1a-469b-a689-d0733e59ceb9 61 fields · synced May 17, 2026
- EUDAMED a3307c58-b6a9-43f8-a33b-613259e12fa4 61 fields · synced May 17, 2026
- EUDAMED 09282165-6bc5-454d-aa5a-5ed4c50186aa 61 fields · synced May 17, 2026
- EUDAMED fb2150e1-c192-4c08-816b-4fb37b671d49 61 fields · synced May 17, 2026
- EUDAMED 04538575-3cdd-441d-873f-55d019d5f53f 61 fields · synced May 17, 2026
- EUDAMED 4a399e29-7988-4a79-9648-cd3449a292f8 61 fields · synced May 17, 2026
- EUDAMED 1ca09383-972b-441b-8fe8-984f0401cb9a 61 fields · synced May 17, 2026
- EUDAMED e8e26471-5c24-4d1e-94da-56be7257fc64 61 fields · synced May 17, 2026
- EUDAMED cc210e17-b99e-4ed0-9484-bbef15efc9ef 61 fields · synced May 17, 2026
- EUDAMED 677e6d11-285a-4ccf-a42a-7a8c2615be53 61 fields · synced May 17, 2026
- EUDAMED c0863ea9-0e24-4cc9-9417-7b5f7e080683 61 fields · synced May 17, 2026
- EUDAMED 059aa368-c52d-4536-80f5-7abc6365a82e 61 fields · synced May 17, 2026
- EUDAMED bc6bac21-bdf4-4a5b-89b9-3ed9e150c216 61 fields · synced May 17, 2026
- EUDAMED 5c756d48-fbc5-474f-8b58-37a126ad7401 61 fields · synced May 17, 2026
- EUDAMED 52691493-53c7-44dc-ae47-1ba04ec196ee 61 fields · synced May 17, 2026
- EUDAMED 4dcfd971-7321-4efe-a7fd-148614d29d10 61 fields · synced May 17, 2026
- EUDAMED 77d70d66-588b-4749-a2b9-b0529c05d2ab 61 fields · synced May 17, 2026
- EUDAMED 0a0f6dde-771c-4534-9792-e53c115e2b97 61 fields · synced May 17, 2026
- EUDAMED 15efae09-aa00-453a-8cc2-6e9521965bad 61 fields · synced May 17, 2026
- EUDAMED a58ec249-faf4-4179-a3db-1e424b4cbe09 61 fields · synced May 17, 2026
- EUDAMED 937da8bb-6934-4e72-9c4a-3df3d4259b92 61 fields · synced May 17, 2026
- EUDAMED f5073f13-0bf2-4b5d-891d-69efa3816edd 61 fields · synced May 17, 2026
- EUDAMED 7a695280-0a36-4d61-92d7-786bc1a75f35 61 fields · synced May 17, 2026
- EUDAMED 4d9a9c22-652e-4d62-b1a3-7f7b610a79cc 61 fields · synced May 17, 2026
- EUDAMED 719227d3-f601-44a2-92fd-fbc0df2ace84 61 fields · synced May 17, 2026
- EUDAMED a7629bca-a8a1-4b2e-813a-ca112abdf10c 61 fields · synced May 18, 2026
- EUDAMED 21e1c2d5-7785-4008-88e1-fcd2fad3c2cb 61 fields · synced May 18, 2026
- EUDAMED ef729f23-ff1c-4cc4-bf18-5b4aa98d99f7 61 fields · synced May 18, 2026