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Dummy length sizer for middle ear implants
EUDAMEDClass I (EU MDR)
Ref 12000-D10Ref 11000-D35Ref 11000-D65Ref 12000-D25Ref 11000-D40Ref 11000-D70Ref 12000-D55Ref 12000-D30Ref 11000-D60Ref 11000-D20Ref 11000-D50Ref 12000-D35Ref 12000-D45Ref 11000-D45Ref 12000-D17
Identity
- Device Name
- Dummy length sizer for middle ear implants EUDAMED
- Model / Reference
- 12000-D10 EUDAMED11000-D35 EUDAMED11000-D65 EUDAMED12000-D25 EUDAMED11000-D40 EUDAMED11000-D70 EUDAMED12000-D55 EUDAMED12000-D30 EUDAMED11000-D60 EUDAMED11000-D20 EUDAMED11000-D50 EUDAMED12000-D35 EUDAMED12000-D45 EUDAMED11000-D45 EUDAMED12000-D17 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250381804353 EUDAMED04250381803646 EUDAMED04250381803707 EUDAMED04250381804391 EUDAMED04250381803653 EUDAMED04250381803714 EUDAMED04250381804452 EUDAMED04250381804407 EUDAMED04250381803691 EUDAMED04250381803615 EUDAMED04250381803677 EUDAMED04250381804414 EUDAMED04250381804438 EUDAMED04250381803660 EUDAMED04250381804377 EUDAMED
- Basic UDI-DI
- B-04250381804353 EUDAMEDB-04250381803646 EUDAMEDB-04250381803707 EUDAMEDB-04250381804391 EUDAMEDB-04250381803653 EUDAMEDB-04250381803714 EUDAMEDB-04250381804452 EUDAMEDB-04250381804407 EUDAMEDB-04250381803691 EUDAMEDB-04250381803615 EUDAMEDB-04250381803677 EUDAMEDB-04250381804414 EUDAMEDB-04250381804438 EUDAMEDB-04250381803660 EUDAMEDB-04250381804377 EUDAMED
- EMDN Code
- P020180 OTOLOGIC PROSTHESES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Dummy length sizer for middle ear implants by SPIGGLE & THEIS Medizintechnik GmbH — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250381804353 | Class I | Active |
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Manufacturer
- Manufacturer
- SPIGGLE & THEIS Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000006647
Sources (15)
- EUDAMED 94c66f16-237b-4106-ac92-843d1ddcb991 61 fields · synced Sep 18, 2026
- EUDAMED 8046b63b-3708-41e4-be7a-c5f28d5df0df 61 fields · synced May 16, 2026
- EUDAMED d513bbad-003a-499a-90dd-e5f8d1d6d9e4 61 fields · synced May 16, 2026
- EUDAMED 4d6ac182-503c-4036-bd48-02d9a5452a64 61 fields · synced May 16, 2026
- EUDAMED 8e56cb3f-e9fe-4ddd-a48d-7e3f32434dba 61 fields · synced May 17, 2026
- EUDAMED 8b07cb65-550d-4786-bf07-0dda304175b0 61 fields · synced May 17, 2026
- EUDAMED 67116b83-802c-48c7-96d0-8a3ff8388c02 61 fields · synced May 17, 2026
- EUDAMED da72d0f3-e3c5-4b0f-8ddf-9135a7c5dcb9 61 fields · synced May 18, 2026
- EUDAMED fe256393-1af3-47cf-b3e9-97cb4438041f 61 fields · synced May 18, 2026
- EUDAMED 7f1ad6bc-dab1-4cdf-a58a-2a36feed330b 61 fields · synced May 18, 2026
- EUDAMED 5ad05f8f-2602-43fa-9b44-957d1f235bb3 61 fields · synced May 18, 2026
- EUDAMED 07f11d0a-bc6d-4efa-af6f-288b36dcf31d 61 fields · synced May 18, 2026
- EUDAMED 90d7fc1d-1833-4b4b-850c-950510b4f8c0 61 fields · synced May 18, 2026
- EUDAMED 5fbd152d-0847-4c1a-a817-be84ef464916 61 fields · synced May 18, 2026
- EUDAMED 4a6e0e20-91bc-4c5d-a946-6b4409c90890 61 fields · synced May 19, 2026