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Spirecut
EUDAMEDClass I (EU MDR)
Ref SB-01-01.01Ref KIT-SI-CT-01.01Ref KIT-SI-TF-01.01
by Spirecut AG
Identity
- Trade Name
- SPIRECUT EUDAMED
- Device Name
- Sono-Bath EUDAMEDCarpal Tunnel Sono Instrument EUDAMEDTrigger Finger Sono-Instrument EUDAMED
- Model / Reference
- SB-01-01.01 EUDAMEDKIT-SI-CT-01.01 EUDAMEDKIT-SI-TF-01.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649988948725 EUDAMED07649988948701 EUDAMED07649988948718 EUDAMED
- Basic UDI-DI
- 76499889487SBSM EUDAMED76499889487KIT-CT-SI3A EUDAMED76499889487KIT-TF-SI63 EUDAMED
- EMDN Code
- V0480 CLINICAL USE CONTAINERS (NON-IVD) - ACCESSORIES EUDAMEDV0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
Category: Surgical instrument/implant rack
Spirecut by Spirecut AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 76499889487SBSM | Class I | Active |
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Manufacturer
- Manufacturer
- Spirecut AG
- EUDAMED SRN
- CH-MF-000030994
- Authorised Representative
- Medicina Legatis SRL BE-AR-000026599
Sources (3)
- EUDAMED 0120a12d-f560-49f8-a88f-57151a9eee65 61 fields · synced Sep 18, 2026
- EUDAMED 5168bad6-4d47-4f6f-a91a-a696fe3637a3 61 fields · synced May 17, 2026
- EUDAMED 00f011ce-4cf9-460e-82ac-8d0e5b30c65c 61 fields · synced May 18, 2026