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Pomo
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel POMO, POMO W, POMO PModel POMO
by B&L Biotech
Identity
- Trade Name
- POMO EUDAMEDPOMO Black FDA UDI
- Generic Name
- Dental material heater FDA UDI
- Device Name
- POMO EUDAMED
- Model / Reference
- POMO, POMO W, POMO P EUDAMEDnone EUDAMEDPOMO EUDAMEDPOMB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019110651 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191POMOPU EUDAMEDB-08800019110651 EUDAMED
- FDA Product Code
- KXR FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material heater FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3140 FDA UDI
- Market of Registration
- Denmark 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
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 UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pomo by B&L Biotech — 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 | 88000191POMOPU | Class I | Active |
| EUDAMED | European Union | CE/MDR | 88000191POMOPU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED fdd8d499-4e5b-4bbc-873e-808dc6e2dea9 61 fields · synced Jun 19, 2026
- EUDAMED 21f0c000-c464-449e-bdd6-3d152de219bb 61 fields · synced May 19, 2026
- FDA UDI 3d806fef-bf35-47d6-9bd5-a22a0e218486 32 fields · synced May 29, 2026
- EUDAMED fdd8d499-4e5b-4bbc-873e-808dc6e2dea9-1 61 fields · synced Jun 10, 2026