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Endo Gutta Pack Pro
EUDAMEDClass IIa (EU MDR)
Ref 6380034Model Endo Gutta Pack Pro
Identity
- Trade Name
- Endo Gutta Pack Pro EUDAMED
- Device Name
- Endodontic Obturation Device EUDAMED
- Model / Reference
- Endo Gutta Pack Pro EUDAMED6380034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975132957352 EUDAMED
- Basic UDI-DI
- B-06975132957352 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Endo Gutta Pack Pro by Changzhou Sifary Medical Technology Co., Ltd. — Class IIa — 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-06975132957352 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Sifary Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010405
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED ad345ffe-f665-41ca-955d-a7ef76783300 61 fields · synced Jun 18, 2026