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ANSER Clavicle Pin Set
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref ANS-301SModel Intramedullary fracture fixation device
Identity
- Trade Name
- ANSER Clavicle Pin Set EUDAMED
- Device Name
- ANSER Clavicle Pin Set EUDAMED
- Model / Reference
- Intramedullary fracture fixation device EUDAMEDANS-301S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719425460727 EUDAMED
- Basic UDI-DI
- B-08719425460727 EUDAMED
- EMDN Code
- P09120202 INTRAMEDULLARY NAILS IN COMPLEX SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
ANSER Clavicle Pin Set by BAAT Medical Products B.V. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201830 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08719425460727 | Class IIb | Active |
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Manufacturer
- Manufacturer
- BAAT Medical Products B.V.
- EUDAMED SRN
- NL-MF-000001569
Sources (2)
- EUDAMED 307d4a14-3893-4147-9a90-c9f14fdf77a6 61 fields · synced Jul 29, 2026
- FDA 510(k) K201830 1 fields · synced May 18, 2026