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Orteza
EUDAMEDClass I (EU MDR)
Ref P-5907739317476Model OrtezaRef P-5905973407304Ref P-5907739317988Ref P-5907739318176Ref P-5907739317902Ref P-5905973407205Ref P-5905973407311Ref P-5907739317933Ref P-5907739317643Ref P-5905973407274Ref P-5907739317780Ref P-5907739317940Ref P-5907739318299Ref P-5905973407298Ref P-5907739317964Ref P-5907739317858Ref P-5905973407267Ref P-5905973400558Ref P-5907739317841Ref P-5907739317773Ref P-5907739317995Ref P-5907739319227Ref P-5907739318084Ref P-5905973407243Ref P-5907739317834Ref P-5907739318053Ref P-5907739317803Ref P-5907739317889Ref P-5907739317971Ref P-5907739318091Ref P-5907739318015Ref P-5907739317926Ref P-5907739317537Ref P-5907739317605Ref P-5907739317612Ref P-5905973400480Ref P-5907739317483
Identity
- Trade Name
- ORTEZA EUDAMED
- Device Name
- Orteza EUDAMED
- Model / Reference
- Orteza EUDAMEDP-5907739317476 EUDAMEDP-5905973407304 EUDAMEDP-5907739317988 EUDAMEDP-5907739318176 EUDAMEDP-5907739317902 EUDAMEDP-5905973407205 EUDAMEDP-5905973407311 EUDAMEDP-5907739317933 EUDAMEDP-5907739317643 EUDAMEDP-5905973407274 EUDAMEDP-5907739317780 EUDAMEDP-5907739317940 EUDAMEDP-5907739318299 EUDAMEDP-5905973407298 EUDAMEDP-5907739317964 EUDAMEDP-5907739317858 EUDAMEDP-5905973407267 EUDAMEDP-5905973400558 EUDAMEDP-5907739317841 EUDAMEDP-5907739317773 EUDAMEDP-5907739317995 EUDAMEDP-5907739319227 EUDAMEDP-5907739318084 EUDAMEDP-5905973407243 EUDAMEDP-5907739317834 EUDAMEDP-5907739318053 EUDAMEDP-5907739317803 EUDAMEDP-5907739317889 EUDAMEDP-5907739317971 EUDAMEDP-5907739318091 EUDAMEDP-5907739318015 EUDAMEDP-5907739317926 EUDAMEDP-5907739317537 EUDAMEDP-5907739317605 EUDAMEDP-5907739317612 EUDAMEDP-5905973400480 EUDAMEDP-5907739317483 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907739317476 EUDAMED05905973407304 EUDAMED05907739317988 EUDAMED05907739318176 EUDAMED05907739317902 EUDAMED05905973407205 EUDAMED05905973407311 EUDAMED05907739317933 EUDAMED05907739317643 EUDAMED05905973407274 EUDAMED05907739317780 EUDAMED05907739317940 EUDAMED05907739318299 EUDAMED05905973407298 EUDAMED05907739317964 EUDAMED05907739317858 EUDAMED05905973407267 EUDAMED05905973400558 EUDAMED05907739317841 EUDAMED05907739317773 EUDAMED05907739317995 EUDAMED05907739319227 EUDAMED05907739318084 EUDAMED05905973407243 EUDAMED05907739317834 EUDAMED05907739318053 EUDAMED05907739317803 EUDAMED05907739317889 EUDAMED05907739317971 EUDAMED05907739318091 EUDAMED05907739318015 EUDAMED05907739317926 EUDAMED05907739317537 EUDAMED05907739317605 EUDAMED05907739317612 EUDAMED05905973400480 EUDAMED05907739317483 EUDAMED05905973407250 EUDAMED
- Basic UDI-DI
- 590773931ORTEZAUT EUDAMED
- EMDN Code
- Y060603 FINGERS ORTHOSES EUDAMEDY06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMEDY061209 KNEE ORTHOSES EUDAMEDY060609 WRIST (FOREARM) ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Orteza by 4fizjo Group Sp. Z O. O. — 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 | 590773931ORTEZAUT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 4fizjo Group Sp. Z O. O.
- EUDAMED SRN
- PL-MF-000031702
Sources (38)
- EUDAMED 8d3fb6ca-cd5d-47db-a443-5b929e2b8d09 61 fields · synced Oct 6, 2026
- EUDAMED 41d074a7-fed9-4d6b-8fa4-37670f41b273 61 fields · synced May 16, 2026
- EUDAMED 001d06be-d833-422d-bb92-0a8d79253a1f 61 fields · synced May 16, 2026
- EUDAMED fbcc7a7f-6ad8-43eb-b16d-dba5fd3b42a9 61 fields · synced May 16, 2026
- EUDAMED 69d021dc-a793-42fd-883e-f6bdeaaaf7be 61 fields · synced May 17, 2026
- EUDAMED c5680019-ae98-4fae-a9a2-98ba43301180 61 fields · synced May 17, 2026
- EUDAMED d0273aa9-a080-452c-92ce-45b5b615956d 61 fields · synced May 17, 2026
- EUDAMED 332a253d-b361-48ff-a1cf-0001f58c034e 61 fields · synced May 17, 2026
- EUDAMED 55ff37dd-d333-4dca-af3d-ea55cb808fe3 61 fields · synced May 17, 2026
- EUDAMED 9502547f-df79-489d-bab6-dc3efe2dbe12 61 fields · synced May 17, 2026
- EUDAMED 4c315039-4fd4-4271-ab9f-ca7c741fd16f 61 fields · synced May 17, 2026
- EUDAMED 9c4a5d4d-2883-40c5-8e59-52affd24c54e 61 fields · synced May 17, 2026
- EUDAMED 77e95320-3e3c-4b4d-8108-c0f7bfccf2e8 61 fields · synced May 17, 2026
- EUDAMED f9de01e1-8916-404c-a812-2138c8354a77 61 fields · synced May 17, 2026
- EUDAMED 2434a203-513f-4fd5-aa08-854ae03ee61d 61 fields · synced May 17, 2026
- EUDAMED 1454ef3f-2765-476d-96ae-1aa383cc3ae4 61 fields · synced May 17, 2026
- EUDAMED ba1910e1-61df-4a3a-8dba-32d5415e833f 61 fields · synced May 17, 2026
- EUDAMED ca4a7bf7-eb47-4c21-9505-4b70e96c207e 61 fields · synced May 17, 2026
- EUDAMED 807e78b5-3483-4aa0-947f-0acc43356751 61 fields · synced May 17, 2026
- EUDAMED 0d7b9303-63df-4a7b-90e3-f07ada84cf8a 61 fields · synced May 18, 2026
- EUDAMED b0b5bf8d-a570-4d3e-ba13-cc24af3fa755 61 fields · synced May 18, 2026
- EUDAMED 01805cda-3102-4bca-8843-4ff323f73424 61 fields · synced May 18, 2026
- EUDAMED bba42dbc-d626-4a21-b5cc-11e154bb2b79 61 fields · synced May 18, 2026
- EUDAMED 0841918d-3e28-4dcd-9323-5d2827e01c9a 61 fields · synced May 18, 2026
- EUDAMED 3357f85b-956b-464e-8816-85ea7a169127 61 fields · synced May 18, 2026
- EUDAMED f818b403-07d3-4502-ac46-2b88d7fda8df 61 fields · synced May 18, 2026
- EUDAMED a34dd75f-8ca1-465c-97aa-273cd98caca4 61 fields · synced May 18, 2026
- EUDAMED 8236cb47-a884-4ad5-805b-eba253501b49 61 fields · synced May 18, 2026
- EUDAMED dd5b1c25-4afb-4e29-8b96-a5904a8d670c 61 fields · synced May 18, 2026
- EUDAMED d9c7db6b-f952-43de-bca2-47a48aa4008b 61 fields · synced May 18, 2026
- EUDAMED 4f38c709-8fa3-4e3b-88fd-a7f846ea8e3d 61 fields · synced May 18, 2026
- EUDAMED c3cb9093-4bc2-4dca-9849-2d6abe5c9ffc 61 fields · synced May 18, 2026
- EUDAMED b4aeca45-b5c5-4d6d-bbce-21171bb4fa3f 61 fields · synced May 18, 2026
- EUDAMED cdcadfbc-5f03-4ae1-8283-ccfff98b577f 61 fields · synced May 18, 2026
- EUDAMED 844cc47d-4ca3-4042-973e-e91bed30dc3e 61 fields · synced May 18, 2026
- EUDAMED 5e2e47e4-2b61-4e83-898d-f88f0c103a45 61 fields · synced May 19, 2026
- EUDAMED 1d8d40fa-bdac-42dd-9753-617a08169eb3 61 fields · synced May 19, 2026
- EUDAMED d2d94b55-5585-47f3-8c21-e5a6c303df3f 61 fields · synced May 19, 2026