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Philips Lumea
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BRI984Ref BRI983Ref BRC332Ref BRC344Ref BRI930Ref BRI938Ref BRI934Ref BRI982Ref BRI937Ref BRC343Ref BRC342Ref BRI931Ref BRI933Ref BRC341
Identity
- Trade Name
- Philips Lumea IPL FDA UDI
- Generic Name
- Home-use intense pulsed light hair removal unit FDA UDI
- Device Name
- Philips Lumea EUDAMED
- Model / Reference
- BRI984 EUDAMEDFDA UDIBRI983 EUDAMEDBRC332 EUDAMEDBRC344 EUDAMEDBRI930 EUDAMEDBRI938 EUDAMEDBRI934 EUDAMEDBRI982 EUDAMEDBRI937 EUDAMEDBRC343 EUDAMEDBRC342 EUDAMEDBRI931 EUDAMEDBRI933 EUDAMEDBRC341 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720689035910 EUDAMED08720689035880 EUDAMED08720689044806 EUDAMED08720689045667 EUDAMED08720689049887 EUDAMED08720689035187 EUDAMED08710103917069 EUDAMED08720689051415 EUDAMED08720689018838 EUDAMED08720689044790 EUDAMED08720689051477 EUDAMED08720689049078 EUDAMED08720689020114 EUDAMED08720689019163 EUDAMED08720689046671 EUDAMED08720689049092 EUDAMED08720689045698 EUDAMED08720689018951 EUDAMED08720689046367 EUDAMED08720689044813 EUDAMED00075020107763 FDA UDI
- Basic UDI-DI
- 8710103BM1173AG EUDAMED
- Direct Marketing DI
- 08720689035910 EUDAMED08720689035880 EUDAMED08720689044806 EUDAMED08720689045667 EUDAMED08720689049887 EUDAMED08720689035187 EUDAMED08710103917069 EUDAMED08720689051415 EUDAMED08720689018838 EUDAMED08720689044790 EUDAMED08720689051477 EUDAMED08720689049078 EUDAMED08720689020114 EUDAMED08720689019163 EUDAMED08720689046671 EUDAMED08720689049092 EUDAMED08720689045698 EUDAMED08720689018951 EUDAMED08720689046367 EUDAMED08720689044813 EUDAMED
- 510(k) Number
- K243453 FDA UDI
- FDA Product Code
- OHT FDA UDIGEX FDA UDI
- EMDN Code
- Z12040201 PHOTOEPILATION EQUIPMENT EUDAMED
- GMDN Term
- Home-use intense pulsed light hair removal unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Poland EUDAMEDNetherlands 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Philips Lumea by Philips Consumer Lifestyle B.V. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8710103BM1173AG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Consumer Lifestyle B.V.
- EUDAMED SRN
- NL-MF-000001693
Sources (21)
- EUDAMED 458f28f8-c3d2-46c4-8315-47c79c375e96 61 fields · synced Sep 18, 2026
- EUDAMED 0a71e7b4-b299-4912-bcc2-22d9d24ad9c1 61 fields · synced May 16, 2026
- EUDAMED b4590473-9e26-483c-ba38-828877214b92 61 fields · synced May 17, 2026
- EUDAMED 281ae6d2-2713-4e7d-80c0-59ad43a1da4f 61 fields · synced May 17, 2026
- EUDAMED f672e253-1f06-415f-82b0-ce7bc1c841f0 61 fields · synced May 17, 2026
- EUDAMED 94b23005-5810-4e5e-8ead-1a35db2688e8 61 fields · synced May 17, 2026
- EUDAMED 31818d56-d510-4543-b7ee-b9c6fe1512e7 61 fields · synced May 17, 2026
- EUDAMED 2b5de2d4-b4c3-4110-8a55-744511bf8d20 61 fields · synced May 17, 2026
- EUDAMED ee74dc9b-8bba-4b3e-9c0b-3aa0140b70ba 61 fields · synced May 17, 2026
- EUDAMED 43562720-b0e0-4c63-a402-8a143d919cb1 61 fields · synced May 17, 2026
- EUDAMED cf032e7b-4ba8-4b78-9f77-35a940d1f0b7 61 fields · synced May 17, 2026
- EUDAMED b9d61c45-9519-48fc-a33c-1fe43872c120 61 fields · synced May 17, 2026
- EUDAMED f80cc984-79c0-41db-8fa3-fc6207ee1085 61 fields · synced May 17, 2026
- EUDAMED 59517529-6313-4fac-90d1-7869dcc16f54 61 fields · synced May 18, 2026
- FDA UDI 616c9f01-997a-4823-9fcb-5ad5c65aa7be 34 fields · synced May 30, 2026
- EUDAMED 509e1036-1f9f-4f91-ba57-34254dfce121 61 fields · synced Jul 11, 2026
- EUDAMED ae27f482-fe68-4710-a4b6-e1aa19dddf43 61 fields · synced Jul 12, 2026
- EUDAMED 2c1a92c9-5c2d-4409-b665-ee2b0178e4c4 61 fields · synced Jul 14, 2026
- EUDAMED 8720d89e-227b-442e-8c53-4581ed98f32e 61 fields · synced Jul 29, 2026
- EUDAMED 618d9723-7cd6-4343-adb2-7e400ea43572 61 fields · synced Aug 2, 2026
- EUDAMED f35bd02e-ff51-42e9-9a62-d89572902776 61 fields · synced Sep 18, 2026