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Dummy length sizer for middle ear implants
EUDAMEDClass I (EU MDR)
Ref 12000-D05
Identity
- Device Name
- Dummy length sizer for middle ear implants EUDAMED
- Model / Reference
- 12000-D05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250381804346 EUDAMED
- Basic UDI-DI
- B-04250381804346 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-04250381804346 | Class I | Active |
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Manufacturer
- Manufacturer
- SPIGGLE & THEIS Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000006647
Sources (1)
- EUDAMED 99b7d590-0462-48da-80a0-ddd54ad158e9 61 fields · synced Jun 18, 2026