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Henry Schein
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9001481Model TF-172 (HS)Ref 9009022Model TF-026Ref 9009023Ref 9009011Model TF-025Ref 9006437Model TF-169Ref 9882141Model TF-053Ref 9004091Model TF-061Ref 9880525Ref 9001283Ref 9883490Model TF-198Ref 9006438Model TF-167Ref 9004090Ref 9002100Ref 9009407Ref 9006697Model TF-393 (HS)Ref 9009408Ref 9001282Ref 9009751Ref 9001281
Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDIHS EUDAMEDHenrySchein FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDIInfrared patient thermometer, ear FDA UDI
- Device Name
- Instrument Trays EUDAMEDPaper Points EUDAMEDGutta Percha Points EUDAMEDDigital Thermometer EUDAMEDVaginal Speculum, disposable, sterile EUDAMEDMaxiTemp(1016) EUDAMEDTemporary Cement, Eugenol EUDAMEDEar Thermometer infrared EUDAMEDECG Electrode EUDAMEDMaxiTemp HP Kit FDA UDIInfared Ear Thermometer FDA UDI
- Model / Reference
- TF-172 (HS) EUDAMED9001481 EUDAMED9004091 EUDAMEDFDA UDI9006438 EUDAMEDFDA UDI9001281 EUDAMEDFDA UDI9004090 EUDAMEDFDA UDI9001282 EUDAMEDFDA UDITF-026 EUDAMED9009022 EUDAMED9009023 EUDAMEDTF-025 EUDAMED9009011 EUDAMEDTF-169 EUDAMED9006437 EUDAMEDTF-053 EUDAMED9882141 EUDAMEDTF-061 EUDAMED9880525 EUDAMED9001283 EUDAMEDTF-198 EUDAMED9883490 EUDAMEDTF-167 EUDAMED9002100 EUDAMED9009407 EUDAMEDTF-393 (HS) EUDAMED9006697 EUDAMED9009408 EUDAMED9009751 EUDAMED
- Description
- MaxiTemp HP Kit FDA UDIInfared Ear Thermometer FDA UDI
Identifiers
- Catalog Number
- 9004091 FDA UDI9006438 FDA UDI9001281 FDA UDI9004090 FDA UDI9001282 FDA UDI
- Primary DI / UDI-DI
- 00304040142967 EUDAMED00304040001561 EUDAMEDFDA UDI00304040001615 EUDAMEDFDA UDI00304040001530 EUDAMEDFDA UDI00304040001578 EUDAMEDFDA UDI00304040001523 EUDAMEDFDA UDI10304040096656 EUDAMED10304040096663 EUDAMED10304040096502 EUDAMED00304040082010 EUDAMED10304040060473 EUDAMED10304040060459 EUDAMED10304040036027 EUDAMED00304040063774 EUDAMED10304040036034 EUDAMED10304040060435 EUDAMED10304040188306 EUDAMED10304040060442 EUDAMED10304040096779 EUDAMED
- Basic UDI-DI
- 03040417201C7 EUDAMEDB-10304040096656 EUDAMEDB-10304040096663 EUDAMEDB-10304040096502 EUDAMEDB-00304040082010 EUDAMEDB-10304040060473 EUDAMEDB-00304040001561 EUDAMEDB-10304040060459 EUDAMEDB-10304040036027 EUDAMEDB-00304040063774 EUDAMEDB-00304040001615 EUDAMEDB-00304040001578 EUDAMEDB-10304040036034 EUDAMEDB-10304040060435 EUDAMED03040439301DG EUDAMEDB-10304040060442 EUDAMEDB-00304040001523 EUDAMEDB-10304040096779 EUDAMEDB-00304040001530 EUDAMED
- Unit of Use DI
- 00304040188309 EUDAMED
- FDA Product Code
- EBG FDA UDIFLL FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMEDQ01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMEDV0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMEDU089006 VAGINAL SPECULUM, SINGLE-USE EUDAMEDQ010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMEDQ0101010203 TEMPORARY DENTAL CEMENTS EUDAMEDC020501 ECG ELECTRODES EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDIInfrared patient thermometer, ear FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI880.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMED
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDIEUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDIFDA UDI
Over-the-Counter
No
FDA UDIFDA UDI
Convenience Kit
No
FDA UDIFDA UDI
Combination Product
No
FDA UDIFDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
MR Safe FDA 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 | 03040417201C7 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 03040417201C7 | 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 (24)
- EUDAMED 45077d28-cbb9-4d22-9fb0-7a421149e53c 61 fields · synced Sep 30, 2026
- FDA UDI 88f26341-dcbe-4dd4-adcd-42664cb21bb0 35 fields · synced May 29, 2026
- FDA UDI f328d51e-b835-4025-b9a3-88edc0716d11 35 fields · synced May 30, 2026
- FDA UDI 9b467268-1bd3-4e37-8153-0c643934f3d5 35 fields · synced May 30, 2026
- FDA UDI a14e9c4f-7da8-44a8-aa87-09df151ea4e8 35 fields · synced May 30, 2026
- FDA UDI 8ef1ed40-c389-4462-af2b-5bb1f29423b8 35 fields · synced May 30, 2026
- EUDAMED 680f4bff-c6ff-4ffb-b5cf-307030435992 61 fields · synced Jul 8, 2026
- EUDAMED ac0337f9-36d6-4e1a-9771-0557322d20f2 61 fields · synced Jul 8, 2026
- EUDAMED 099e055c-7dd0-4b72-ae3e-d5dcb985d026 61 fields · synced Jul 8, 2026
- EUDAMED 6b65be8b-d5f0-418a-b338-e6c577b8714f 61 fields · synced Jul 9, 2026
- EUDAMED 6e359750-b350-4456-b657-c419c704d1bf 61 fields · synced Jul 9, 2026
- EUDAMED c61e700e-b70f-43ff-888b-df50ad3e5447 61 fields · synced Jul 16, 2026
- EUDAMED f0b66714-6565-49b4-89e0-ddb91f5f0c09 61 fields · synced Jul 16, 2026
- EUDAMED 67f6fbb4-cadd-408e-9be3-5dd243d41171 61 fields · synced Jul 17, 2026
- EUDAMED bec56375-75eb-484f-9f54-3c011b29ddfe 61 fields · synced Jul 17, 2026
- EUDAMED e13e55b2-1976-4bd4-af4a-91bf76ef7fff 61 fields · synced Jul 18, 2026
- EUDAMED 2864c743-a618-4e78-bcf1-13b5524f687f 61 fields · synced Jul 23, 2026
- EUDAMED 64bded69-cbea-46de-81a5-eeaf1001c5ea 61 fields · synced Jul 26, 2026
- EUDAMED 36297f3b-aa6b-4a7c-b7de-4362c16fb2b7 61 fields · synced Jul 26, 2026
- EUDAMED dc5caae5-d52b-490a-b90a-4b8665ab23bc 61 fields · synced Jul 27, 2026
- EUDAMED d59f39b5-d5ae-4eef-8bd2-80d1d2b51950 61 fields · synced Jul 30, 2026
- EUDAMED e92b08d0-25f8-4a98-bd40-9967b5619667 61 fields · synced Aug 1, 2026
- EUDAMED 27c36e55-db74-43e5-8073-0ad0afbd9d63 61 fields · synced Sep 30, 2026
- EUDAMED edd9d476-62c9-40c1-b2c7-b5e43962db73 61 fields · synced Sep 30, 2026