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Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System

EUDAMED

Class I (EU MDR)

Ref IOC-124Ref FDB-12Ref IOC-050Ref FDB-20Ref TCP-004Ref IOC-061Ref TPO-005Ref IDS-03Ref IMF-L04Ref IOC-072Ref ODS-02Ref FDB-13Ref IOC-161Ref FDB-08Ref TCM-004Ref FDB-21Ref IOC-171Ref IOC-032Ref ODS-01Ref IOC-122Ref IOC-052Ref MDS-02Ref ODB-10Ref IOC-094Ref IOC-073Ref ODB-04Ref IOC-131Ref IOC-092Ref IOC-020Ref IDS-02Ref FDS-01Ref FDB-14Ref MDB-10Ref IOC-012Ref TCP-003Ref IOC-151Ref IDS-01Ref MDS-03Ref FDB-06Ref TPM-006Ref TPF-005Ref IOC-125Ref FDB-02Ref IOC-126Ref IOC-021Ref FDS-02Ref IOC-170Ref TPM-005Ref IOC-127Ref IOC-120

by OSTEONIC Co., Ltd.

Identity

Trade Name
Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System EUDAMED
Device Name
Surgical Instrument EUDAMED
Model / Reference
IOC-124 EUDAMED
FDB-12 EUDAMED
IOC-050 EUDAMED
FDB-20 EUDAMED
TCP-004 EUDAMED
IOC-061 EUDAMED
TPO-005 EUDAMED
IDS-03 EUDAMED
IMF-L04 EUDAMED
IOC-072 EUDAMED
ODS-02 EUDAMED
FDB-13 EUDAMED
IOC-161 EUDAMED
FDB-08 EUDAMED
TCM-004 EUDAMED
FDB-21 EUDAMED
IOC-171 EUDAMED
IOC-032 EUDAMED
ODS-01 EUDAMED
IOC-122 EUDAMED
IOC-052 EUDAMED
MDS-02 EUDAMED
ODB-10 EUDAMED
IOC-094 EUDAMED
IOC-073 EUDAMED
ODB-04 EUDAMED
IOC-131 EUDAMED
IOC-092 EUDAMED
IOC-020 EUDAMED
IDS-02 EUDAMED
FDS-01 EUDAMED
FDB-14 EUDAMED
MDB-10 EUDAMED
IOC-012 EUDAMED
TCP-003 EUDAMED
IOC-151 EUDAMED
IDS-01 EUDAMED
MDS-03 EUDAMED
FDB-06 EUDAMED
TPM-006 EUDAMED
TPF-005 EUDAMED
IOC-125 EUDAMED
FDB-02 EUDAMED
IOC-126 EUDAMED
IOC-021 EUDAMED
FDS-02 EUDAMED
IOC-170 EUDAMED
TPM-005 EUDAMED
IOC-127 EUDAMED
IOC-120 EUDAMED

Identifiers

Primary DI / UDI-DI
08809399749123 EUDAMED
08809416061214 EUDAMED
08809399746207 EUDAMED
08809416062938 EUDAMED
08809416063874 EUDAMED
08800071002666 EUDAMED
08809416063843 EUDAMED
08809595970758 EUDAMED
08809399747136 EUDAMED
08809416063805 EUDAMED
08809399746139 EUDAMED
08809416061221 EUDAMED
08809416061436 EUDAMED
08809416061177 EUDAMED
08809416063911 EUDAMED
08809539692807 EUDAMED
08809416062884 EUDAMED
08809416063799 EUDAMED
08809399746122 EUDAMED
08809399749048 EUDAMED
08809416063928 EUDAMED
08809399746153 EUDAMED
08809416061269 EUDAMED
08809399746283 EUDAMED
08809416063812 EUDAMED
08809399745989 EUDAMED
08809539692784 EUDAMED
08809399746269 EUDAMED
08809399746221 EUDAMED
08809595970741 EUDAMED
08809399746108 EUDAMED
08809416061238 EUDAMED
08809399749185 EUDAMED
08809416063751 EUDAMED
08809416063867 EUDAMED
08809416061412 EUDAMED
08809595970734 EUDAMED
08809416061375 EUDAMED
08809416061450 EUDAMED
08809416063898 EUDAMED
08809416063836 EUDAMED
08809399749116 EUDAMED
08809399745910 EUDAMED
08809399749109 EUDAMED
08809416062860 EUDAMED
08809399746115 EUDAMED
08809416062877 EUDAMED
08809416063881 EUDAMED
08809399749260 EUDAMED
08809399749178 EUDAMED
Basic UDI-DI
B-08809399749123 EUDAMED
B-08809416061214 EUDAMED
B-08809399746207 EUDAMED
B-08809416062938 EUDAMED
B-08809416063874 EUDAMED
B-08800071002666 EUDAMED
B-08809416063843 EUDAMED
B-08809595970758 EUDAMED
B-08809399747136 EUDAMED
B-08809416063805 EUDAMED
B-08809399746139 EUDAMED
B-08809416061221 EUDAMED
B-08809416061436 EUDAMED
B-08809416061177 EUDAMED
B-08809416063911 EUDAMED
B-08809539692807 EUDAMED
B-08809416062884 EUDAMED
B-08809416063799 EUDAMED
B-08809399746122 EUDAMED
B-08809399749048 EUDAMED
B-08809416063928 EUDAMED
B-08809399746153 EUDAMED
B-08809416061269 EUDAMED
B-08809399746283 EUDAMED
B-08809416063812 EUDAMED
B-08809399745989 EUDAMED
B-08809539692784 EUDAMED
B-08809399746269 EUDAMED
B-08809399746221 EUDAMED
B-08809595970741 EUDAMED
B-08809399746108 EUDAMED
B-08809416061238 EUDAMED
B-08809399749185 EUDAMED
B-08809416063751 EUDAMED
B-08809416063867 EUDAMED
B-08809416061412 EUDAMED
B-08809595970734 EUDAMED
B-08809416061375 EUDAMED
B-08809416061450 EUDAMED
B-08809416063898 EUDAMED
B-08809416063836 EUDAMED
B-08809399749116 EUDAMED
B-08809399745910 EUDAMED
B-08809399749109 EUDAMED
B-08809416062860 EUDAMED
B-08809399746115 EUDAMED
B-08809416062877 EUDAMED
B-08809416063881 EUDAMED
B-08809399749260 EUDAMED
B-08809399749178 EUDAMED
EMDN Code
L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
S010499 STERILISATION CONTAINERS - OTHER EUDAMED
L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
L091399 ORTHOPAEDIC SURGERY FORCEPS, REUSABLE - OTHER EUDAMED
L150299 ODONTOSTOMATOLOGY SPREADERS AND RETRACTORS, REUSABLE - OTHER EUDAMED
L0927 ORTHOPAEDIC SURGERY MANUAL PERFORATORS, REUSABLE EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Greece EUDAMED
Bulgaria EUDAMED
Spain EUDAMED
Portugal EUDAMED
Italy EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Non-sterile CMF (Cranio Maxillofacial Fixation) Instrument System by OSTEONIC CO., Ltd. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
OSTEONIC Co., Ltd.
EUDAMED SRN
KR-MF-000008969
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (50)

  • EUDAMED 17d483a4-5152-41c4-a6e8-06ebbe44085f 61 fields · synced Sep 18, 2026
  • EUDAMED 4eb8a22a-bca5-44f4-968c-3cd3524feef0 61 fields · synced May 11, 2026
  • EUDAMED 51288a62-5161-4c26-9ab0-b7abe5ed1da5 61 fields · synced May 11, 2026
  • EUDAMED 7e2d0992-30b7-40ef-a36a-7212da567be4 61 fields · synced May 11, 2026
  • EUDAMED a40539cd-a9bc-455c-820a-d5537c5c5c84 61 fields · synced May 11, 2026
  • EUDAMED ea79231b-b976-4063-8566-ad07945600bd 61 fields · synced May 11, 2026
  • EUDAMED 674883c9-afac-4a82-a74c-56c7eab1895b 61 fields · synced May 16, 2026
  • EUDAMED cb6af113-e710-403e-a65e-f2e709a52ed1 61 fields · synced May 16, 2026
  • EUDAMED a940a542-e97b-477f-b90f-0bb9028da2fe 61 fields · synced May 16, 2026
  • EUDAMED a67010eb-06e4-4154-b451-213ec2ab57c1 61 fields · synced May 16, 2026
  • EUDAMED 38a9f4b5-679c-4a7a-b3ec-0d271a9b36ce 61 fields · synced May 16, 2026
  • EUDAMED 1c09ee71-73da-4ad8-b0b0-1d7bc65397d7 61 fields · synced May 16, 2026
  • EUDAMED 438835d0-88e8-4b2c-b999-32189fe85c70 61 fields · synced May 17, 2026
  • EUDAMED d09a02a8-ccd1-4652-9f0b-12b2f7980d59 61 fields · synced May 17, 2026
  • EUDAMED db0ca58d-2dd5-451e-b6b5-fa363cb57285 61 fields · synced May 17, 2026
  • EUDAMED 962df2c0-b98c-4028-b6f8-a37863797ecf 61 fields · synced May 17, 2026
  • EUDAMED 26c67ede-c8d7-4b60-90c3-a586d18cf58c 61 fields · synced May 17, 2026
  • EUDAMED a725b9cd-9be2-4eb0-b96b-39023f42b3ea 61 fields · synced May 17, 2026
  • EUDAMED d664486f-b9d5-4fd2-b796-8d137947b4b2 61 fields · synced May 17, 2026
  • EUDAMED 12c37f7a-ea63-4e30-8654-e4f674549ddd 61 fields · synced May 17, 2026
  • EUDAMED b9670ec6-fd37-494c-a450-5c2f721f0b50 61 fields · synced May 17, 2026
  • EUDAMED 5e51fda1-989e-4e5a-8610-a9d0e8275d93 61 fields · synced May 17, 2026
  • EUDAMED e7d9e436-0dc9-4d33-a293-6c7c22e68f48 61 fields · synced May 17, 2026
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  • EUDAMED 30dbd30e-571b-4ce8-a563-141578afc38c 61 fields · synced May 17, 2026
  • EUDAMED b08b1c12-f8d1-4824-a822-f909456abafc 61 fields · synced May 18, 2026
  • EUDAMED 03b35a31-4671-40a8-b20c-c9b2cfdde9e6 61 fields · synced May 18, 2026
  • EUDAMED 54ecfa4a-0fa6-469e-8d1e-f81164711809 61 fields · synced May 18, 2026
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  • EUDAMED e1b86039-0b17-44d2-8f26-6d18e149f875 61 fields · synced May 18, 2026
  • EUDAMED c8d18a32-b14c-4b82-ad67-014243622eb7 61 fields · synced May 18, 2026
  • EUDAMED c71cffe5-469e-4ed2-b06c-e96f9c68e6ee 61 fields · synced May 18, 2026
  • EUDAMED cab899fb-0389-4274-b802-8edfcb8dbe0a 61 fields · synced May 18, 2026
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  • EUDAMED 265d55d3-b435-4e33-b1ca-dc80fb7ebad7 61 fields · synced May 18, 2026
  • EUDAMED 1be9766c-a389-42cc-ba42-85f62daf1bb6 61 fields · synced May 18, 2026
  • EUDAMED 68f5c428-cccf-4d57-b7e8-85d69bb5512f 61 fields · synced May 19, 2026
  • EUDAMED ba8ac1b6-9921-4b19-831d-0f5301733b57 61 fields · synced May 19, 2026
  • EUDAMED 076ce4f5-7fe0-4983-be55-c32699f03364 61 fields · synced May 19, 2026
  • EUDAMED da6d5e05-9ce9-4bd9-8ac1-ef84411c12b7 61 fields · synced May 19, 2026
  • EUDAMED 39b2c51d-ed81-4d90-8e95-c9a0791b4537 61 fields · synced May 19, 2026
  • EUDAMED e5976647-43c2-455c-b6fe-18e11a6d1c67 61 fields · synced May 19, 2026
  • EUDAMED 68a165ad-318f-49ab-97d4-75ab8ed15953 61 fields · synced May 19, 2026
  • EUDAMED b1f39e42-3167-44a9-9ad5-267ca1a19eda 61 fields · synced May 19, 2026
  • EUDAMED 180ba966-a5e8-4472-adf6-5d2b8c471fe3 61 fields · synced May 19, 2026