Identity
- Trade Name
- TERUMO DENTAL NEEDLE EUDAMED
- Device Name
- TERUMO DENTAL NEEDLE EUDAMED
- Model / Reference
- DN*M3019 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987350739445 EUDAMED
- Basic UDI-DI
- B-04987350739445 EUDAMED
- EMDN Code
- A010601 CARPULE NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Terumo Dental Needle by Air Water Realize Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-04987350739445 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Air Water Realize Inc.
- EUDAMED SRN
- JP-MF-000029803
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED cb5f055e-b131-4393-9263-8f03883d8270 61 fields · synced Sep 17, 2026
- EUDAMED 06779e8b-403c-4a1d-aba5-c601bea4a316 61 fields · synced Jun 20, 2026