Identity
- Trade Name
- INJECTA EUDAMED
- Device Name
- HYPODERMIC SYRINGE EUDAMED
- Model / Reference
- SS-6087 EUDAMEDSS-6085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265608786 EUDAMED08907265608502 EUDAMED08907265608564 EUDAMED08907265608779 EUDAMED08907265608731 EUDAMED08907265608595 EUDAMED
- Basic UDI-DI
- 8907265M0022U EUDAMED
- EMDN Code
- A020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMEDA020102020101 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Injecta 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 | 8907265M0022U | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (6)
- EUDAMED f9b4bcd1-a777-42e0-850b-10adbb1829f9 61 fields · synced Jul 29, 2026
- EUDAMED d72ef0dc-ced3-4acb-91d6-26a02ee7aa67 61 fields · synced May 17, 2026
- EUDAMED cbcbc760-805c-4b3a-b9a6-77bae2823cef 61 fields · synced May 17, 2026
- EUDAMED 3f6ec004-4620-4d3f-b4e6-5f3f271fb7ef 61 fields · synced May 17, 2026
- EUDAMED 351867b2-dbd6-4483-ba98-90607ad1190e 61 fields · synced May 19, 2026
- EUDAMED 7888b009-c4f5-4ca9-b2b7-bfc7e9e98d2a 61 fields · synced Jul 20, 2026