Identity
- Trade Name
- HYPODERMIC NEEDLE EUDAMEDMEDIGLIDE EUDAMED
- Device Name
- HYPODERMIC NEEDLE EUDAMED
- Model / Reference
- SS-6088 EUDAMEDSS-6092 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265030389 EUDAMED08907265030006 EUDAMED08907265030136 EUDAMED08907265030075 EUDAMED08907265030129 EUDAMED08907265030037 EUDAMED08907265030501 EUDAMED08907265030150 EUDAMED08907265030068 EUDAMED08907265030044 EUDAMED08907265030778 EUDAMED08907265030020 EUDAMED08907265030082 EUDAMED
- Basic UDI-DI
- 8907265N0012Z EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hypodermic Needle by Romsons Group Private Limited — 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 | 8907265N0012Z | Class IIa | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (14)
- EUDAMED 3d4334c2-0e61-4f07-9935-af20fb4b5cd1 61 fields · synced Aug 1, 2026
- EUDAMED 6d607847-2cd4-4b3f-9ca5-fbbe4e8f6343 61 fields · synced Jun 11, 2026
- EUDAMED cb229202-c92b-4010-8702-573b3556ccd9 61 fields · synced Jun 20, 2026
- EUDAMED 07d163f1-a0ac-473e-a142-4d48aa320638 61 fields · synced Jul 9, 2026
- EUDAMED 4753cead-25bb-46f5-ba9d-9bbea78392dd 61 fields · synced Jul 9, 2026
- EUDAMED 370d9239-4b76-4c27-a6c1-34d2f0e26434 61 fields · synced Jul 10, 2026
- EUDAMED 1e4b7e43-19f0-4cd5-8947-a8fbab6fd08e 61 fields · synced Jul 11, 2026
- EUDAMED ea5bde3c-137f-4541-9a3a-af1f7c036d0b 61 fields · synced Jul 11, 2026
- EUDAMED 8ac9c1f5-b7f8-46e3-930a-27c70bf7fb05 61 fields · synced Jul 13, 2026
- EUDAMED d4c681c4-5a03-4596-81d3-34e568f0cca7 61 fields · synced Jul 14, 2026
- EUDAMED 062f8b21-3b1a-40fc-ba82-48e45c1e8685 61 fields · synced Jul 16, 2026
- EUDAMED 8ee57d56-8683-43e8-9bf1-f91e45d77937 61 fields · synced Jul 20, 2026
- EUDAMED a95fb2d7-bd8f-4e15-a300-c3cbec472497 61 fields · synced Jul 23, 2026
- EUDAMED 8d6c9c4e-ec15-4c57-8b90-19842d8ac817 61 fields · synced Aug 1, 2026