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Pro Burnout Sleeve for TCT-N
EUDAMEDClass I (EU MDR)
Ref 5218Model Lab Accessories
Identity
- Trade Name
- Pro Burnout Sleeve for TCT-N EUDAMED
- Model / Reference
- Lab Accessories EUDAMED5218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290117810279 EUDAMED
- Basic UDI-DI
- 72901178Lab2G EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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
Pro Burnout Sleeve for TCT-N by Alpha Bio Tec 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 | 72901178Lab2G | Class I | Active |
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Manufacturer
- Manufacturer
- Alpha Bio Tec Ltd.
- EUDAMED SRN
- IL-MF-000021145
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 9fe3a869-3c3e-4574-8cbc-0f601518f35e 61 fields · synced Jun 19, 2026
- EUDAMED f52df6db-8cda-4281-96ab-189e3f663b41 61 fields · synced Jun 19, 2026