1. Isitifiketi se-ISO 13485 (Idivayisi Yezokwelapha i-QMS)
| Kungani Kubalulekile? | Okufanele Uqinisekise |
|---|
| Iqinisekisa ukulandeleka okugcwele, ukulawulwa kobungozi, nokuthobela imithetho yamadivayisi okuxhumana nesikhumba | Hlola Iwebhusayithi ye-Sunsred: Mayelana - Isitifiketi |
| I-Sunsred: Iqinisekiswe i-ISO 13485 kusukela ngo-2020 - ububanzi obugcwele | |
2. Igumbi Lokuhlanza Elingenalo Uthuli (Ikilasi elingu-100,000 noma Elingcono)
Ingozi Ngaphandle Kwayo | I-Premium Standard |
|---|
Uthuli → ukwehluleka kwe-LED, ukucasuka kwesikhumba, isikhunta ku-silicone | ≥1,500 m² igumbi lokuhlanza eline-HEPA, ESD, ukulawula izinga lokushisa/umswakama |
I-Sunsred: 1,750 m² Igumbi lokuhlanza Lekilasi 100,000 — alukho uthuli olubonakalayo eminyakeni engu-5 |
3. Izinto Zebanga Lezokwelapha + Izinamathiselo Ezigunyazwe I-FDA
| Kushibhile uma kuqhathaniswa ne-Premium | Okufanele Ube Nobufakazi |
|---|
| Iqinisekisa ukulandeleka okugcwele, ukulawulwa kobungozi, nokuthobela imithetho yamadivayisi okuxhumana nesikhumba | Ukuthobela kwe-FDA 510(k) noma 21 CFR 175.300 kuwo wonke ama-glues nama-silicones |
Ama-chips e-LED angaziwa → ubude begagasi obungalungile, i-irradiance ephansi | Imibiko yokuhlolwa kwe-Spectral (isb, 630±5nm, 850±10nm) |
I-Sunsred: Isebenzisa i-FDA-cleared glue (K243978) + i-silicone ewuketshezi yebanga lokudla | |
4. Ukuhlolwa kokuguga okungu-100% kwe-Piece-by-piece (≥4 Amahora)
Isilinganiso Semboni | I-Premium Benchmark |
|---|
10% amasampula okungahleliwe → 2–5% ukwehluleka kwenkambu | Yonke iyunithi ihlolwe amahora angu-4+ ngamandla aphelele |
Kukhanye ilanga: amahora angu-4 ukushiswa imaski ngayinye → izinga lokwehluleka <0.5% | |
![Izinto Eziyisi-7 Ezibalulekile Zokukhetha Umkhiqizi Wemaski Wobuso Be-LED Oyi-Premium 2]()
5. I-FDA 510(k) Imvume noma i-CE MDR Class IIa
Ingozi “Yokubhaliswa Kwe-FDA” Kuphela | Kusho ukuthini Premium |
|---|
Akusho lutho - uhlu lwesizindalwazi kuphela | Ukuvunyelwa kwangempela (inombolo-K) noma ifayela lobuchwepheshe le-MDR |
I-Sunsred M2/M4: FDA 510(k) K243978 | |
I-Sunsred SR B4: CE MDR + FDA indlela iyaqhubeka | |
6. I-Wavelength eqondile ne-Irradiance (Iqinisekisiwe ilebhu)
Amamaski e-LED ashibhile | I-Premium Standard |
|---|
“630nm” = empeleni 610–650nm → i-zero collagen boost | ±5nm ukubekezelela + ≥30 mW/cm² (bomvu/NIR) |
I-Sunsred SR B4: - Okubomvu+NIR: 35 mW/cm²
- Okuhlaza okwesibhakabhaka: 15 mW/cm²
- Imibiko yelebhu yenkampani yangaphandle iyatholakala
| |
![Izinto Eziyisi-7 Ezibalulekile Zokukhetha Umkhiqizi Wemaski Wobuso Be-LED Oyi-Premium 3]()
7. Ukuguquguquka kwe-OEM + Ukuvikelwa kwe-IP
Amafulegi Abomvu | Ukusekelwa kwe-Premium |
|---|
"Kopisha umklamo wakho" ngaphandle kwe-NDA | Kusayinwe i-NDA + EU/US amalungelo obunikazi efayelini |
MOQ 5,000+ | Amayunithi e-MOQ 200 anelogo/iphakheji yangokwezifiso |
I-Sunsred: - Amalungelo obunikazi e-EU & US & UK & AU kumklamo ongenalutho we-SR B4
- Isampula yezinsuku ezi-3 Izinsuku ezingama-30-35 ngobuningi
| |
Uhlu Lokuhlola Olusheshayo: Ingabe Umhlinzeki Wakho Uyi-Premium Ngempela?
Umbuzo Yebo = I-Premium Sunsred |
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I-ISO 13485 iqinisekisiwe? ✅ ✅ |
| Igumbi lokuhlanza elingenalo uthuli ≥1,500 m²? ✅ ✅ 1750m² |
Ukuhlolwa kokuguga kwamahora angu-4 ngeyunithi ngayinye? ✅ ✅ |
| Iglue esulwe yi-FDA + ama-LED ezokwelapha? ✅ ✅ K243978 |
| Imibiko yelebhu ye-Wavelength? ✅ ✅ ±5nm |
| I-MOQ ≤200 + NDA? ✅ ✅ |
Isinqumo Sokugcina
I-Premium ayiyona into enanini — yinqubo. Khetha umkhiqizi ophatha umkhiqizo wakho njengedivayisi yezokwelapha , hhayi ithoyizi.
I-Sunsred ihlola wonke amabhokisi - futhi ithumela e- EU/USA/Australia ngokuthobela okuphelele.
Ulungele ikhwalithi yebanga lasemtholampilo ngamanani aqondile asefekthri?
WhatsApp: +86 158 2046 5032 (Sasa)
www.sunsred.com
Thola isampula yakho yamahhala + imibiko yelebhu namuhla.
Umkhiqizo wakho ufanelwe okungcono kakhulu. Unganeliseki ngokuthi "okwanele."
