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Henry Schein
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9880499Model TF-332 (HS)Ref 9009044Model TF-156 (HS)Ref 5721246Model TF-338Ref 5701784Model TF-123
Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Stand-on floor scale, mechanical FDA UDIManual endodontic file/rasp, reusable FDA UDI
- Device Name
- Sensor sleeves - HS EUDAMEDDisposable Barrier Sleeves EUDAMEDOrthodontic Wires EUDAMEDRotary NiTi file U Coro CX orange 19mm EUDAMEDEndoflex K-Files 21mm FDA UDI
- Model / Reference
- TF-332 (HS) EUDAMED9880499 EUDAMED5701784 EUDAMEDFDA UDITF-156 (HS) EUDAMED9009044 EUDAMEDTF-338 EUDAMED5721246 EUDAMEDTF-123 EUDAMED112-7157 FDA UDI
- Description
- Endoflex K-Files 21mm FDA UDI
Identifiers
- Catalog Number
- 5701784 FDA UDI
- Primary DI / UDI-DI
- 10304040143688 EUDAMED10304040127206 EUDAMEDFDA UDI10304040116699 EUDAMED10304040106515 EUDAMED06970934290034 FDA UDI
- Basic UDI-DI
- 03040433201BZ EUDAMED03040415601CD EUDAMEDB-10304040106515 EUDAMEDB-10304040127206 EUDAMED
- Unit of Use DI
- 00304040143681 EUDAMED00304040116692 EUDAMED
- FDA Product Code
- FRI FDA UDIEKS FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMEDQ010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMEDQ010405 ORTHODONTIC WIRES EUDAMEDQ010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Stand-on floor scale, mechanical FDA UDIManual endodontic file/rasp, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMED
- Regulation Number
- 880.2700 FDA UDI872.4565 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 UDIFDA UDI
Reprocessed
Yes
EUDAMEDEUDAMED
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
Prescription Use
No
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 UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDIFDA UDI
Henry Schein by Henry Schein, Inc. — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 03040433201BZ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 03040433201BZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein Inc.
- EUDAMED SRN
- US-MF-000021683
- Authorised Representative
- Henry Schein Services GmbH DE-AR-000008001
Sources (6)
- EUDAMED 0d761fc8-5806-4248-9dde-ee8112501dc6 61 fields · synced Jul 28, 2026
- FDA UDI 4c58f739-30a5-4927-91d1-7b8cbccd700f 32 fields · synced May 24, 2026
- FDA UDI ae60d0ee-6a76-4bdc-93df-9dfa0f9d926c 34 fields · synced May 30, 2026
- EUDAMED 3acfc2bd-133f-4b3d-ab2c-4a4e24ce9cf2 61 fields · synced Jul 17, 2026
- EUDAMED 1620a426-957f-4011-9fe3-bc49fd2fd7e9 61 fields · synced Jul 21, 2026
- EUDAMED 65e08bc8-c769-4e8e-8c65-cf552ea43ab6 61 fields · synced Jul 24, 2026