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Ergänzungs-Set LSK Gyn
EUDAMEDClass IIb (EU MDR)
Ref 66818617-04Model 66810273-14
Identity
- Trade Name
- Ergänzungs-Set LSK Gyn EUDAMED
- Device Name
- Tumor-OP-Set EUDAMED
- Model / Reference
- 66810273-14 EUDAMED66818617-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04034393759074 EUDAMED
- Basic UDI-DI
- 4034393CPTGEN2BWH EUDAMED
- EMDN Code
- U010299 URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Sterile, disposable procedure pack, combination of devices for injury or disease treatment related to general surgery. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
Ergänzungs-Set LSK Gyn by Sengewald Klinikprodukte GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
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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 | 4034393CPTGEN2BWH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sengewald Klinikprodukte GmbH
- EUDAMED SRN
- DE-PR-000020748
Sources (1)
- EUDAMED 6361f14f-a3be-4b2b-94cb-52fe3692c65e 61 fields · synced Sep 18, 2026