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Froozer
EUDAMEDClass IIa (EU MDR)
Ref 06501010Model FROOZER
by Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.
Identity
- Trade Name
- FROOZER EUDAMED
- Model / Reference
- FROOZER EUDAMED06501010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904507650346 EUDAMED
- Basic UDI-DI
- B-05904507650346 EUDAMED
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Category: Fixture/appliance dental drill bit, reusable
Froozer by Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Fixture/appliance dental drill bit, reusable.
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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-05904507650346 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- PL-MF-000038261
Sources (1)
- EUDAMED c5c48e27-b0d7-489f-9589-d839244c496a 61 fields · synced Oct 6, 2026