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First Gel Direct Stick Packs
EUDAMEDClass I (EU MDR)
Ref 00230-0607-48Model 200
Identity
- Device Name
- First Gel Direct Stick Packs EUDAMED
- Model / Reference
- 200 EUDAMED00230-0607-48 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08836913463944 EUDAMED
- Basic UDI-DI
- 08836912008S EUDAMED
- EMDN Code
- Z12069099 VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
First Gel Direct Stick Packs by Professional Products, Inc. — 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 | 08836912008S | Class I | Active |
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Manufacturer
- Manufacturer
- Professional Products, Inc.
- EUDAMED SRN
- US-MF-000019828
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 9c8c5d59-6ce5-4927-ab21-a71fdb33a466 61 fields · synced Jun 18, 2026