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Neal Cast Flex
EUDAMEDClass I (EU MDR)
Ref NEC-2P-WHModel Orthopedic Casting tapeRef NEC-1P-WHRef NEC-5P-WH
by BL Tech
Identity
- Trade Name
- Neal Cast Flex EUDAMED
- Device Name
- Orthopedic Casting tape EUDAMED
- Model / Reference
- Orthopedic Casting tape EUDAMEDNEC-2P-WH EUDAMEDNEC-1P-WH EUDAMEDNEC-5P-WH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809270461922 EUDAMED08809270461564 EUDAMED08809270462769 EUDAMED
- Basic UDI-DI
- 880927046CASTKU EUDAMED
- EMDN Code
- M030504 IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPERATURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Neal Cast Flex by BL Tech — 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 | 880927046CASTKU | Class I | Active |
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Manufacturer
- Manufacturer
- BL Tech
- EUDAMED SRN
- KR-MF-000013035
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 3495599c-24e1-4cd2-9776-3cb8484c3271 61 fields · synced Jul 26, 2026
- EUDAMED f9fe38d8-075b-48e0-83f8-e0bbdd0e9a57 61 fields · synced May 17, 2026
- EUDAMED 86e077ff-2c07-4c7a-a524-24b443c6d72d 61 fields · synced May 18, 2026