Identity
- Trade Name
- SPRDN EUDAMED
- Device Name
- SuperEndo-Alpha II EUDAMED
- Model / Reference
- CL-A1 EUDAMEDSPRDN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019100249 EUDAMED
- Basic UDI-DI
- 88000191ALPHAFS EUDAMEDB-08800019100249 EUDAMED
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Sprdn by B&L Biotech — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 88000191ALPHAFS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000191ALPHAFS | Class IIa | Active |
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Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 53a0de2f-8ab5-4ccf-9195-6cb7505c6687 61 fields · synced Jul 8, 2026
- EUDAMED 8f4376b2-e502-4c37-9645-06e59acb4947 61 fields · synced Jun 18, 2026