Identity
- Device Name
- Pullback unit EUDAMED
- Model / Reference
- PU3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971318441288 EUDAMED
- Basic UDI-DI
- 697131844002P8Z EUDAMED
- EMDN Code
- Z1104018099 ULTRASOUND SCANNERS – HARDWARE ACCESSORIES – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Pullback unit by Insight Lifetech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697131844002P8Z | Class I | Active |
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Manufacturer
- Manufacturer
- Insight Lifetech Co., Ltd.
- EUDAMED SRN
- CN-MF-000011205
- Authorised Representative
- MedNet EC-REP C III GmbH DE-AR-000011196
Sources (1)
- EUDAMED 48ee8b77-51cd-47b5-bd45-11c2601ee2f7 61 fields · synced Jun 18, 2026