← Back to catalogue
Prime|one
EUDAMEDClass I (EU MDR)
Ref STPAA26-AKZ-GR-C55Ref MICAP25-AKZ-CE-FNERef MICAP25-AKZ-WH-SFNRef STRAA26-AKZ-GR-C50Ref STRAA26-AKZ-GR-C93Ref STRAA26-AKZ-GR-C46Ref BENAA25-AKZ-ST-C89Ref MICAP25-AKZ-MC-FNERef STPAA26-AKZ-BL-C53Ref STPAA26-AKZ-BL-C55Ref STPAA26-AKZ-BL-C85Ref STPAA26-AKZ-GR-C53Ref MICAP25-AKZ-PI-REGRef STRAA26-AKZ-BL-C46Ref STPAA26-AKZ-GR-C85Ref STPAA26-AKZ-BL-C57Ref STPAA26-AKZ-BL-C92Ref STPAA26-AKZ-BL-C54Ref STRAA26-AKZ-BL-C51Ref BENAA25-AKZ-ST-C91Ref GLOCL60-AKZ-WH-S01Ref HLXAA26-AKZ-ST-UNIRef GLOBY53-AKZ-TL-LL1Ref BDDAA26-AKZ-ST-UNIRef GLOBY53-AKZ-TL-XS1Ref GLOBN53-AKZ-DW-LL1Ref GLOBN53-AKZ-DW-XS1
Identity
- Trade Name
- PRIME|ONE EUDAMED
- Device Name
- STERILIZATION REELS AND BAGS EUDAMEDMICRO APPLICATORS EUDAMEDBARRIER ENVELOPES EUDAMEDGLOVES EUDAMEDHELIX TEST EUDAMEDBOWIE & DICK TEST PACK EUDAMED
- Model / Reference
- STPAA26-AKZ-GR-C55 EUDAMEDMICAP25-AKZ-CE-FNE EUDAMEDMICAP25-AKZ-WH-SFN EUDAMEDSTRAA26-AKZ-GR-C50 EUDAMEDSTRAA26-AKZ-GR-C93 EUDAMEDSTRAA26-AKZ-GR-C46 EUDAMEDBENAA25-AKZ-ST-C89 EUDAMEDMICAP25-AKZ-MC-FNE EUDAMEDSTPAA26-AKZ-BL-C53 EUDAMEDSTPAA26-AKZ-BL-C55 EUDAMEDSTPAA26-AKZ-BL-C85 EUDAMEDSTPAA26-AKZ-GR-C53 EUDAMEDMICAP25-AKZ-PI-REG EUDAMEDSTRAA26-AKZ-BL-C46 EUDAMEDSTPAA26-AKZ-GR-C85 EUDAMEDSTPAA26-AKZ-BL-C57 EUDAMEDSTPAA26-AKZ-BL-C92 EUDAMEDSTPAA26-AKZ-BL-C54 EUDAMEDSTRAA26-AKZ-BL-C51 EUDAMEDBENAA25-AKZ-ST-C91 EUDAMEDGLOCL60-AKZ-WH-S01 EUDAMEDHLXAA26-AKZ-ST-UNI EUDAMEDGLOBY53-AKZ-TL-LL1 EUDAMEDBDDAA26-AKZ-ST-UNI EUDAMEDGLOBY53-AKZ-TL-XS1 EUDAMEDGLOBN53-AKZ-DW-LL1 EUDAMEDGLOBN53-AKZ-DW-XS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476623852 EUDAMED04250476618285 EUDAMED04250476618384 EUDAMED04250476626013 EUDAMED04250476626044 EUDAMED04250476625092 EUDAMED04250476600587 EUDAMED04250476618308 EUDAMED04250476624507 EUDAMED04250476624545 EUDAMED04250476624583 EUDAMED04250476623814 EUDAMED04250476618315 EUDAMED04250476625023 EUDAMED04250476623890 EUDAMED04250476624569 EUDAMED04250476624606 EUDAMED04250476624521 EUDAMED04250476625078 EUDAMED04250476600624 EUDAMED04250476605117 EUDAMED04250476601171 EUDAMED04250476645281 EUDAMED04250476600709 EUDAMED04250476645342 EUDAMED04250476644338 EUDAMED04250476644277 EUDAMED
- Basic UDI-DI
- 42504766STAB EUDAMED42504766MICUL EUDAMED42504766BENT7 EUDAMED42504766GLOUP EUDAMED42504766HLXVE EUDAMED42504766BDDSG EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM EUDAMEDQ019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMEDS01020101 FLAT STERILISATION REELS, PAPER/PLASTIC FILM EUDAMEDT030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMEDT010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMEDS9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMEDT01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDLithuania EUDAMEDItaly EUDAMEDNetherlands EUDAMEDGermany EUDAMEDHungary EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prime|one by Akzenta International SA — Class I — 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 | 42504766STAB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (27)
- EUDAMED 6ef42b6f-9492-4bc5-857e-c0ce18d5c06a 61 fields · synced Oct 6, 2026
- EUDAMED 3fd861c4-8404-4e8a-b3f7-e1b651182056 61 fields · synced May 16, 2026
- EUDAMED c2da15e4-9de0-4e71-be52-c0d0adf518ce 61 fields · synced May 16, 2026
- EUDAMED d29d0889-9ac2-414b-843c-1cc33ee28c6f 61 fields · synced May 17, 2026
- EUDAMED 14770886-1ded-4cbc-b0bd-63e1645169bb 61 fields · synced May 17, 2026
- EUDAMED 3b5b42c6-cdbe-47a3-aa6c-171b84aae985 61 fields · synced May 17, 2026
- EUDAMED bcdf550e-29e4-40ca-b3ba-fb2b0218a833 61 fields · synced May 17, 2026
- EUDAMED d185f1cb-e30c-47a2-af7e-e19bba2f7600 61 fields · synced May 17, 2026
- EUDAMED 2be9a5b0-9b7d-4f98-b282-21302350f860 61 fields · synced May 17, 2026
- EUDAMED e7ee8a98-1dce-4c6b-92af-ed0c2876ab76 61 fields · synced May 18, 2026
- EUDAMED a62fd2b2-1bb0-4d10-beba-ec553bc216fb 61 fields · synced May 18, 2026
- EUDAMED 685c68d9-357b-4cfa-92f3-6167a73aebcd 61 fields · synced May 18, 2026
- EUDAMED 0c35f73e-36f1-4f16-b21e-4ebdbe56b6de 61 fields · synced May 18, 2026
- EUDAMED ae41dcca-38a0-403f-8031-76c8bc0d82fe 61 fields · synced May 18, 2026
- EUDAMED e31d69b1-5ca3-4d9f-a3dd-eb358f77f05a 61 fields · synced May 18, 2026
- EUDAMED 9586ef27-d9ee-4c6a-a583-2b5e12fd602a 61 fields · synced May 18, 2026
- EUDAMED 15f04300-0b3b-4bb0-a4ad-06e0b2f11390 61 fields · synced May 18, 2026
- EUDAMED b1ed9cec-ff22-4d15-ba7e-a5fd74b8e753 61 fields · synced May 18, 2026
- EUDAMED ed6b291a-5d40-422f-a240-089c1f5fe443 61 fields · synced May 18, 2026
- EUDAMED 111116ad-20f6-458d-8cbc-2c965c5154ab 61 fields · synced May 19, 2026
- EUDAMED b2679d7c-0253-4f94-8639-da226185ac7d 61 fields · synced Jul 10, 2026
- EUDAMED 934d7e05-6e0a-4fd9-ac33-b8fcf27ebab5 61 fields · synced Jul 13, 2026
- EUDAMED 795cbbae-51c8-4a4f-8487-5063839df3a3 61 fields · synced Jul 19, 2026
- EUDAMED 7323b44e-66f1-4d88-bef1-202b8c041279 61 fields · synced Jul 22, 2026
- EUDAMED bb7b06ba-535f-46c4-b4ee-8ebdb1004842 61 fields · synced Jul 22, 2026
- EUDAMED f9ac5e6e-6f9a-4266-a260-cb1cd16d3a44 61 fields · synced Aug 3, 2026
- EUDAMED a215cdfa-28d5-4917-a08f-23691d3fa9d2 61 fields · synced Aug 3, 2026