Identity
- Device Name
- 11000-D55 EUDAMED
- Model / Reference
- 11000-D55 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250381803684 EUDAMED
- Basic UDI-DI
- B-04250381803684 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
11000-D55 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-04250381803684 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SPIGGLE & THEIS Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000006647
Sources (1)
- EUDAMED 1dc1f444-a484-4bd0-af0b-18a14ae54e7a 61 fields · synced Sep 18, 2026