← Back to catalogue
Driver Shaft
EUDAMEDClass I (EU MDR)
Ref IS14-03Ref IS04-H20.32Ref IS04-H25Ref IS01-40HRef IS15-02Ref IS01-20Ref IP20-17Ref IS14-05Ref IS01-10ARef IS05-T25PRef IS01-25Ref IS03-H25PRef IS05-T15.32Ref IS05-T15PRef IS01-35HRef C0024Ref IS04-H25.32Ref IS16-02Ref IS03-H25Ref IS01-40TRef IS05-P44Ref IP20-29Ref IP20-16Ref IS05-T25
Identity
- Trade Name
- Driver Shaft EUDAMEDDriver EUDAMED
- Device Name
- Orthopaedic Instrument EUDAMED
- Model / Reference
- IS14-03 EUDAMEDIS04-H20.32 EUDAMEDIS04-H25 EUDAMEDIS01-40H EUDAMEDIS15-02 EUDAMEDIS01-20 EUDAMEDIP20-17 EUDAMEDIS14-05 EUDAMEDIS01-10A EUDAMEDIS05-T25P EUDAMEDIS01-25 EUDAMEDIS03-H25P EUDAMEDIS05-T15.32 EUDAMEDIS05-T15P EUDAMEDIS01-35H EUDAMEDC0024 EUDAMEDIS04-H25.32 EUDAMEDIS16-02 EUDAMEDIS03-H25 EUDAMEDIS01-40T EUDAMEDIS05-P44 EUDAMEDIP20-29 EUDAMEDIP20-16 EUDAMEDIS05-T25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800045325531 EUDAMED08800045329577 EUDAMED08800045325371 EUDAMED08800045330801 EUDAMED08800045325593 EUDAMED08800045325302 EUDAMED08800045324978 EUDAMED08800045325555 EUDAMED08800045328754 EUDAMED08800045330825 EUDAMED08800045325319 EUDAMED08800045326873 EUDAMED08800045329645 EUDAMED08800045330818 EUDAMED08800045330795 EUDAMED08800045323513 EUDAMED08800045329584 EUDAMED08800045325661 EUDAMED08800045325357 EUDAMED08800045330788 EUDAMED08800045325425 EUDAMED08800045302938 EUDAMED08800045303003 EUDAMED08800045325449 EUDAMED
- Basic UDI-DI
- 88000453BEOTI001KA EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Driver Shaft by ORTHOTECH Co., Ltd — 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 | 88000453BEOTI001KA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ORTHOTECH Co., Ltd
- EUDAMED SRN
- KR-MF-000048890
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (24)
- EUDAMED 88a58984-b035-43bf-a3ed-649cd926f8ae 61 fields · synced Aug 4, 2026
- EUDAMED 185aac1d-a9c8-4da8-8433-6c98edfd774a 61 fields · synced May 11, 2026
- EUDAMED fc516e3a-9377-4e9d-b52a-a54269ac14e3 61 fields · synced May 16, 2026
- EUDAMED 207d9234-3745-426f-b45c-049d9da401f2 61 fields · synced May 16, 2026
- EUDAMED e0e7b241-1b94-4a0c-a66d-97215b5f4ffd 61 fields · synced May 16, 2026
- EUDAMED 58cd273c-150e-4535-80f7-38fd89eb8df9 61 fields · synced May 16, 2026
- EUDAMED aee7b985-d23e-4ff0-8ad5-be6224ed51f8 61 fields · synced May 16, 2026
- EUDAMED 9d99a0a6-c90d-47f1-b480-003fe707e230 61 fields · synced May 17, 2026
- EUDAMED 0bd03c26-87e6-43ca-8d7e-2ca2c8527fed 61 fields · synced May 17, 2026
- EUDAMED 143983df-d4c3-4b58-801a-a623d3383c82 61 fields · synced May 17, 2026
- EUDAMED 94657750-5969-4a6c-bb47-616ba9ebb8ac 61 fields · synced May 17, 2026
- EUDAMED 3377c5ad-2e54-40fb-94cf-5569b8f767ff 61 fields · synced May 17, 2026
- EUDAMED 4937c0cb-6f5f-41b0-a4e5-12cc54918b5a 61 fields · synced May 17, 2026
- EUDAMED fd940df2-232e-476e-af3a-cc7321e396a6 61 fields · synced May 17, 2026
- EUDAMED 3e8fa43a-71be-41b6-9040-cab7d39f8abb 61 fields · synced May 18, 2026
- EUDAMED fd6f300e-9a45-4c30-9615-114ba43bbde0 61 fields · synced May 18, 2026
- EUDAMED a67c9eda-eb5a-4f4b-9c89-14a391c7cfc7 61 fields · synced May 18, 2026
- EUDAMED 4b56ea3b-e8aa-49ff-acd6-13c4efc92ee9 61 fields · synced May 18, 2026
- EUDAMED 401e541f-c302-4672-a71a-755004794310 61 fields · synced May 18, 2026
- EUDAMED be4a1942-0baf-49b1-bc0c-24799d94bac3 61 fields · synced May 18, 2026
- EUDAMED 6c238f02-d93a-4431-8545-5ebc701e2ce4 61 fields · synced May 18, 2026
- EUDAMED 62c926d0-472a-4f2f-bd2c-706afb3440ec 61 fields · synced May 18, 2026
- EUDAMED 5dea7e0b-27ed-4361-9d9c-9a151e3d5210 61 fields · synced May 18, 2026
- EUDAMED 621bf74d-1b43-450f-b779-fe3db9d4f550 61 fields · synced May 19, 2026