Identity
- Trade Name
- FLEX BT TRANSLUCENT EUDAMED
- Device Name
- FLEX BT TRANSLUCENT EUDAMED
- Model / Reference
- B-FBT1TL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00854477006566 EUDAMED
- Basic UDI-DI
- 854477006ALWFBT1TLN6 EUDAMED
- Direct Marketing DI
- 00854477006566 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Flex Bt Translucent by Apply Labwork Inc. — 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 | 854477006ALWFBT1TLN6 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Apply Labwork Inc.
- EUDAMED SRN
- TW-MF-000047057
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED a67cdadf-7cc9-4548-8da4-f5838163a728 61 fields · synced Jul 11, 2026