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Dornier Compact Sigma
EUDAMEDClass IIb (EU MDR)
Ref K1026349Ref K1025662Ref K1025661
Identity
- Trade Name
- Dornier Compact Sigma EUDAMED
- Device Name
- Dornier Compact Sigma EUDAMED
- Model / Reference
- K1026349 EUDAMEDK1025662 EUDAMEDK1025661 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049957000059 EUDAMED04049957000042 EUDAMED04049957000035 EUDAMED
- Basic UDI-DI
- B-04049957000059 EUDAMEDB-04049957000042 EUDAMEDB-04049957000035 EUDAMED
- EMDN Code
- Z12020301 ELECTROMECHANICAL ENDOSCOPIC LITHOTRIPTERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Dornier Compact Sigma by Dornier Medtech Gmbh — Class IIb — 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-04049957000059 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Dornier MedTech GmbH
- EUDAMED SRN
- DE-MF-000009774
Sources (3)
- EUDAMED 1a32b591-667c-492c-8327-40500d237f14 61 fields · synced Jul 23, 2026
- EUDAMED 3cbafb1b-1743-447b-b7b1-e56e9faec353 61 fields · synced May 16, 2026
- EUDAMED 57e78341-c9d1-409e-a8e8-de87a0fcab5f 61 fields · synced May 18, 2026