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Inion Universal instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-9086Ref INS-9045Ref INS-9099Ref INS-9095Ref INS-9094 Ref INS-9089Ref INS-9119Ref IFS-9052Ref INS-9099 Ref INS-9085Ref ACC-9807Ref INS-9089 Ref INS-9094Ref INS-9095
by Inion Oy
Identity
- Trade Name
- Inion Universal instruments EUDAMEDInion FreedomScrew™ instrumentation EUDAMEDInion FreedomScrew Instrumentation EUDAMEDInion® Universal instruments FDA UDIInion FreedomScrew instruments FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDIMedical ruler, reusable FDA UDISurgical countersink, reusable FDA UDISurgical depth gauge, reusable FDA UDIHand-held dental retractor FDA UDI
- Device Name
- Inion Universal instrument EUDAMEDInion Instruments EUDAMEDInion FreedomScrew instrument EUDAMEDDrill guide 1.5/2.0 mm FDA UDIScale for Ø2.0/2.7 mm screws (INS-9110) FDA UDICountersink 2.5/2.8/3.1 (AO-bayonet) FDA UDIDrill guide 4.5 mm FDA UDIDepth gauge 1.5 mm FDA UDICheek retractor FDA UDICountersink 4.5, cannulated (AO-bayonet) FDA UDI
- Model / Reference
- INS-9086 EUDAMEDINS-9045 EUDAMEDINS-9099 EUDAMEDINS-9095 EUDAMEDINS-9094 EUDAMEDINS-9089 EUDAMEDINS-9119 EUDAMEDIFS-9052 EUDAMEDINS-9085 EUDAMEDACC-9807 EUDAMED1 FDA UDI
- Description
- Drill guide 1.5/2.0 mm FDA UDIScale for Ø2.0/2.7 mm screws (INS-9110) FDA UDICountersink 2.5/2.8/3.1 (AO-bayonet) FDA UDIDrill guide 4.5 mm FDA UDIDepth gauge 1.5 mm FDA UDICheek retractor FDA UDICountersink 4.5, cannulated (AO-bayonet) FDA UDI
Identifiers
- Catalog Number
- INS-9099 FDA UDIIFS-9052 FDA UDIINS-9085 FDA UDIINS-9089 FDA UDIINS-9119 FDA UDIINS-9045 FDA UDIINS-9086 FDA UDI
- Primary DI / UDI-DI
- 06438408002953 EUDAMEDFDA UDI06438408002021 EUDAMEDFDA UDI06438408003035 EUDAMEDFDA UDI06438408003028 EUDAMED06438408003011 EUDAMED06438408002984 EUDAMEDFDA UDI06438408003059 EUDAMEDFDA UDI06438408004070 EUDAMEDFDA UDI06438408002946 EUDAMEDFDA UDI06438408002120 EUDAMED
- Basic UDI-DI
- B-06438408002953 EUDAMED6438408INION-IR-INSTRUM9T EUDAMEDB-06438408003011 EUDAMEDB-06438408003059 EUDAMEDB-06438408004070 EUDAMEDB-06438408003035 EUDAMEDB-06438408002946 EUDAMEDB-06438408002120 EUDAMEDB-06438408002984 EUDAMED6438408INION-IRM-INSTRUAF EUDAMED6438408INION-IM-INSTRUM68 EUDAMEDB-06438408002021 EUDAMEDB-06438408003028 EUDAMED
- Secondary DI
- M224INS90459 EUDAMEDM224INS90999 EUDAMEDM224INS909510 EUDAMEDM224INS90899 EUDAMEDM224INS908610 EUDAMEDM224INS91199 EUDAMEDM224IFS90529 EUDAMEDM224INS908510 EUDAMEDM224INS909410 EUDAMED
- Direct Marketing DI
- 06438408003011 EUDAMED06438408003028 EUDAMED06438408002984 EUDAMED06438408003059 EUDAMED06438408003035 EUDAMED06438408002946 EUDAMED06438408002021 EUDAMED06438408004070 EUDAMED06438408002953 EUDAMED
- FDA Product Code
- FZX FDA UDILXH FDA UDIHWW FDA UDIHTJ FDA UDIEIF FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDL091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMEDS010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMEDV0380 DEVICES WITH MEASURING FUNCTIONS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDIMedical ruler, reusable FDA UDISurgical countersink, reusable FDA UDISurgical depth gauge, reusable FDA UDIHand-held dental retractor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI888.4540 FDA UDI888.4300 FDA UDI872.4565 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Inion Universal instruments by Inion Oy — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438408002953 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438408002953 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inion Oy
- EUDAMED SRN
- FI-MF-000000646
Sources (35)
- EUDAMED 34068c71-f500-4e31-91eb-89c4e93857c9 61 fields · synced Aug 3, 2026
- EUDAMED 064d631f-6e37-4e59-bb3f-ba71e4435986 61 fields · synced May 11, 2026
- EUDAMED 1ee492a5-12e3-4ec8-b9fb-f82aa45a2167 61 fields · synced May 16, 2026
- EUDAMED 91dbff44-4423-4c1e-8249-0b1ac5174406 61 fields · synced May 17, 2026
- EUDAMED 6edd99ef-33a6-4270-9fb0-c85922801d7e 61 fields · synced May 17, 2026
- EUDAMED f21fd402-bcd0-4bb8-98fe-8840515caf0b 61 fields · synced May 17, 2026
- EUDAMED d89b3ebb-1dfb-4abe-9140-1c5a7ab28938 61 fields · synced May 17, 2026
- EUDAMED caf04c54-7323-423f-8a12-017e41ba5f9a 61 fields · synced May 17, 2026
- EUDAMED b80cf424-916d-4dbb-af0d-4598c2b6ce16 61 fields · synced May 17, 2026
- EUDAMED c71ee8e3-f392-4201-a830-6d1a88c941c8 61 fields · synced May 18, 2026
- EUDAMED 2f0832d5-5b40-44ab-a221-94489ee2f3f1 61 fields · synced May 18, 2026
- EUDAMED 8c447275-4386-45d8-b013-a9fdce33baf2 61 fields · synced May 18, 2026
- EUDAMED 1bda313a-786c-4d30-8032-80b11f4346ff 61 fields · synced May 19, 2026
- EUDAMED 121ac449-33b6-4b11-8b97-34b8b7f682c8 61 fields · synced May 19, 2026
- EUDAMED d4c8e468-83c5-49d0-ad1e-a5cd084eb7b1 61 fields · synced May 19, 2026
- EUDAMED 4f3d9598-8693-40bd-828a-0cde9c66aa68 61 fields · synced May 19, 2026
- EUDAMED 0c8c962f-430f-4ce0-8bd9-656eb1461016 61 fields · synced May 19, 2026
- EUDAMED 332c82ab-a98b-475f-9a04-16cb67140d14 61 fields · synced May 19, 2026
- EUDAMED f28b503b-9d73-445e-a3f0-8b0539f6b667 61 fields · synced May 19, 2026
- FDA UDI f9f9e2e1-6fcc-4f78-bd62-d5a03cb2a82f 34 fields · synced May 29, 2026
- FDA UDI 13997367-645f-4bd6-9c6d-15cbdd56df07 34 fields · synced May 30, 2026
- FDA UDI dd1dd32a-f0bd-4932-8f2d-5d1fd3359e11 34 fields · synced May 30, 2026
- FDA UDI e38a083b-8b23-43c5-af62-488a91d17711 34 fields · synced May 30, 2026
- FDA UDI 48f215de-b0bf-4e97-ba9b-bb60373f3727 34 fields · synced May 30, 2026
- FDA UDI 850c823f-f1a7-4fa4-801f-0eddd3218d3b 34 fields · synced May 30, 2026
- FDA UDI 994458a9-05fd-4216-befc-a88aea627cc1 34 fields · synced May 30, 2026
- EUDAMED a343b92f-7cb0-4bb6-bf20-9ca9b7ec532e 61 fields · synced Jul 14, 2026
- EUDAMED 6292f9ff-b63c-4ba0-9905-8eac11f784be 61 fields · synced Jul 17, 2026
- EUDAMED 22f760b7-9876-4f5a-a9bc-1b1b95e0f6b3 61 fields · synced Jul 26, 2026
- EUDAMED 60813ca0-2337-4086-b2d6-48cae7a59ec9 61 fields · synced Jul 27, 2026
- EUDAMED c8b34854-7cd0-42d2-a35a-72a6c7f734d5 61 fields · synced Jul 29, 2026
- EUDAMED c55af7c0-10e0-41f6-987d-3a81175f70f6 61 fields · synced Jul 31, 2026
- EUDAMED ea5b19c1-b16f-4fa7-9a27-daaafc3eff86 61 fields · synced Jul 31, 2026
- EUDAMED 87f575e9-c5e3-485d-90ef-480dd09eeef8 61 fields · synced Aug 1, 2026
- EUDAMED c96c8d28-a511-4eb9-aec6-aa4491963eb4 61 fields · synced Aug 3, 2026