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Kare Jet
EUDAMEDClass IIa (EU MDR)
Ref SS-6099Ref SS-6095Ref SS-6096Ref SS-6094Ref SS-6096
Identity
- Trade Name
- KARE JET EUDAMED
- Device Name
- HYPODERMIC SYRINGE EUDAMED
- Model / Reference
- SS-6099 EUDAMEDSS-6095 EUDAMEDSS-6096 EUDAMEDSS-6094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265609950 EUDAMED08907265609561 EUDAMED08907265609929 EUDAMED08907265609608 EUDAMED08907265609417 EUDAMED08907265609523 EUDAMED08907265609615 EUDAMED08907265609516 EUDAMED08907265609967 EUDAMED08907265609462 EUDAMED08907265609431 EUDAMED08907265609530 EUDAMED08907265609455 EUDAMED08907265609646 EUDAMED08907265609936 EUDAMED08907265609912 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 EUDAMEDA020102020101 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE EUDAMEDA020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK 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
Kare 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 (16)
- EUDAMED 2188fa60-49c0-43bf-8509-1d167311b644 61 fields · synced Jul 31, 2026
- EUDAMED 39e1c1fa-2816-4669-bbe3-af2da7f2b76b 61 fields · synced May 11, 2026
- EUDAMED 7c414bf5-73ef-4de5-9780-9bebf4af9e9a 61 fields · synced May 16, 2026
- EUDAMED 5fbb3e37-78bc-497a-a139-f1a1cbdaadab 61 fields · synced May 16, 2026
- EUDAMED b325d867-e669-4c1d-9673-29443abec5ba 61 fields · synced May 17, 2026
- EUDAMED 9973bcf8-30ef-4afe-9b42-01759ffefdf1 61 fields · synced May 17, 2026
- EUDAMED a155bbfb-7eef-4e21-b350-00d7dbb019cf 61 fields · synced May 17, 2026
- EUDAMED dc3638ba-5b38-42fe-9337-0325fdaa607b 61 fields · synced May 18, 2026
- EUDAMED 5f91dc92-9fff-4bd4-a100-d6636237d9fa 61 fields · synced May 18, 2026
- EUDAMED dbe7d7a3-bb72-4505-9428-f213a3b7acf5 61 fields · synced May 19, 2026
- EUDAMED 67150cdd-6f48-474b-8266-c0cfb40b49fb 61 fields · synced May 19, 2026
- EUDAMED a1f1277f-dea3-4250-a974-8e005bd26438 61 fields · synced May 19, 2026
- EUDAMED 59e3b13a-4b74-4ada-ad1d-fea15cc5f176 61 fields · synced May 19, 2026
- EUDAMED 54d4d494-2379-4677-a2b8-5dddd812db02 61 fields · synced May 19, 2026
- EUDAMED d49ae72d-8e24-4131-b90c-44ed819fb650 61 fields · synced May 19, 2026
- EUDAMED 20e64d1d-bc3a-429a-9dc1-a5402d80f5f8 61 fields · synced May 19, 2026