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Stack Splint
EUDAMEDClass I (EU MDR)
Ref 12Model FG-3008 (3)Model FG-3008 (5.5)Model FG-3008 (2)Model FG-3008 (6)
Identity
- Trade Name
- Stack Splint EUDAMED
- Device Name
- Stack Splint EUDAMED
- Model / Reference
- FG-3008 (3) EUDAMED12 EUDAMEDFG-3008 (5.5) EUDAMEDFG-3008 (2) EUDAMEDFG-3008 (6) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976009954344 EUDAMED06976009954375 EUDAMED06976009954337 EUDAMED06976009954382 EUDAMED
- Basic UDI-DI
- 6976009954344DJ EUDAMED6976009954375DV EUDAMED6976009954337DM EUDAMED6976009954382DS EUDAMED
- Direct Marketing DI
- 06976009954344 EUDAMED06976009954375 EUDAMED06976009954337 EUDAMED06976009954382 EUDAMED
- EMDN Code
- V0880 MEDICAL SUPPORT EQUIPMENT - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Stack Splint by Xiamen LongStar Medical Equipment Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6976009954344DJ | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen LongStar Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000034315
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (4)
- EUDAMED 2b54dca7-4c23-423d-bcab-1259a532566a 61 fields · synced Oct 6, 2026
- EUDAMED 1e403546-374c-494c-835e-e47d14f2ed3d 61 fields · synced May 18, 2026
- EUDAMED 25d862a8-dfad-4d40-9a28-2b32d0bf7883 61 fields · synced May 19, 2026
- EUDAMED 4720a166-80a5-40b5-b97e-44a65e7fe3b3 61 fields · synced May 19, 2026