Identity
- Trade Name
- EQ-V EUDAMEDFDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Endodontic Obturation System EUDAMEDPack tip (60/05L), 1ea [V3] FDA UDI
- Model / Reference
- EQ-V EUDAMEDEQV-P37 EUDAMEDFDA UDI
- Description
- Pack tip (60/05L), 1ea [V3] FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809455601020 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809455601020 EUDAMED
- FDA Product Code
- EKR FDA UDI
- EMDN Code
- Q01010299 ROOT CANAL FILLING DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Eq-V by Meta Systems Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809455601020 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Meta Systems Co., Ltd.
- EUDAMED SRN
- KR-MF-000022945
- Authorised Representative
- Meta Biomed Europe GmbH DE-AR-000004953
Sources (2)
- EUDAMED f87c807c-88c6-47f6-903b-fbfc2d409b85 61 fields · synced May 30, 2026
- FDA UDI 4f949561-22ae-47c4-9db4-7ff6582bb9a6 33 fields · synced May 30, 2026