Identity
- Trade Name
- PenBoneE EUDAMED
- Device Name
- PenBoneE EUDAMED
- Model / Reference
- PIE1435/100 EUDAMEDPIE1525/90 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08032986358846 EUDAMED08032986358860 EUDAMED
- Basic UDI-DI
- B-08032986358846 EUDAMEDB-08032986358860 EUDAMED
- EMDN Code
- A01020202 BONE MARROW EXPLANT NEEDLES AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
Category: Bone marrow biopsy needle, single-use
PenBoneE by M.d.l. S.r.l. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Bone marrow biopsy needle, single-use.
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- Faset — Dio Medical Co., Ltd. · U
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08032986358846 | Class IIa | Active |
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Manufacturer
- Manufacturer
- M.D.L. S.r.l.
- EUDAMED SRN
- IT-MF-000011599
Sources (2)
- EUDAMED 7349ee6f-1a90-4863-936d-050e5b3d6c90 61 fields · synced Jul 20, 2026
- EUDAMED 9bad82ba-5d59-4fe0-b029-0d7e703ae149 61 fields · synced May 17, 2026