← Back to catalogue

Platform Treatment Systems

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref 9001Model HS-900

by Shanghai Apolo Medical Technology Co., Ltd.

Identity

Trade Name
Platform Treatment Systems EUDAMED
Apolomed FDA UDI
Generic Name
Multi-modality skin surface treatment system FDA UDI
Device Name
Multi-modality Skin Surface Treatment Systems EUDAMED
Platform Treatment System FDA UDI
Model / Reference
HS-900 EUDAMED
9001 EUDAMED
HS-900K FDA UDI
Description
Platform Treatment System FDA UDI

Identifiers

Primary DI / UDI-DI
06970745919001 EUDAMEDFDA UDI
Basic UDI-DI
B-06970745919001 EUDAMED
510(k) Number
K203395 FDA UDI
FDA Product Code
GEX FDA UDI
EMDN Code
Z12011019 MULTI–PLATFORM LASER EUDAMED
GMDN Term
Multi-modality skin surface treatment system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Market of Registration
Poland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Platform Treatment Systems by Shanghai Apolo Medical Technology Co., Ltd — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000002904
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (3)

  • EUDAMED d0f844d6-2bc6-4923-9054-392b5cf83155 61 fields · synced Jun 18, 2026
  • FDA UDI f42c3e19-5cef-4b75-bc02-0e5c73c6ba83 35 fields · synced May 25, 2026
  • FDA 510(k) K203395 1 fields · synced May 18, 2026