Identity
- Trade Name
- ROMO JET EUDAMED
- Device Name
- HYPODERMIC SYRINGE EUDAMED
- Model / Reference
- SS-6084 EUDAMEDSS-6086 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265608427 EUDAMED08907265608403 EUDAMED08907265608625 EUDAMED08907265608670 EUDAMED08907265608410 EUDAMED08907265608632 EUDAMED08907265608649 EUDAMED08907265608618 EUDAMED08907265608656 EUDAMED08907265608458 EUDAMED08907265608465 EUDAMED08907265608434 EUDAMED
- Basic UDI-DI
- 8907265M0022U EUDAMED
- EMDN Code
- A020102010201 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE EUDAMEDA020102010202 INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT 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
Romo Jet 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 |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (12)
- EUDAMED e4abdf87-60d1-4340-a00d-56b603dfca19 61 fields · synced Oct 1, 2026
- EUDAMED 9c6c12c1-a619-45d8-9ae9-74c6346717cb 61 fields · synced May 16, 2026
- EUDAMED 736e7d84-bd3a-45cc-a2a6-c303100bfe83 61 fields · synced May 17, 2026
- EUDAMED 7f99ad1b-a5c4-417e-b356-646ea22b711c 61 fields · synced May 17, 2026
- EUDAMED 0382584c-0543-4e1c-8e94-5872657b40d3 61 fields · synced May 17, 2026
- EUDAMED c27054ae-d9f0-4021-a41b-780f63d6626e 61 fields · synced May 17, 2026
- EUDAMED a1f73685-e66c-49f4-b151-1fa87531d9bd 61 fields · synced May 18, 2026
- EUDAMED 2072cd49-40f4-44c1-99e4-0e47c21112fb 61 fields · synced May 18, 2026
- EUDAMED 2abfea0b-80d0-429e-9036-8a7d4be5b05c 61 fields · synced May 19, 2026
- EUDAMED 492aebf2-82ec-4ed2-bbee-3079f950c796 61 fields · synced May 19, 2026
- EUDAMED 5bf4fcb6-38eb-4274-8c3e-c02bed5f609e 61 fields · synced May 19, 2026
- EUDAMED d3350273-8c9b-4b86-8459-81a6c721e1f8 61 fields · synced May 19, 2026