Identity
- Device Name
- SEPARADOR 1/2 LUNA gel EUDAMED
- Model / Reference
- 6002.6 EUDAMED6002.5 EUDAMED6002.7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435135500118 EUDAMED08435135500101 EUDAMED08435135500125 EUDAMED
- Basic UDI-DI
- 84351355LUNAGELWA EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Category: Orthotic insole, prefabricated, non-antimicrobial
SEPARADOR 1/2 LUNA gel by Laboratorios Herbitas, S.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthotic insole, prefabricated, non-antimicrobial.
- HAPAD MEDIAL/LATERAL HEEL PADS — Hapad, Inc · Class I
- Passive Ankle-Foot Orthoses — Mammon International Corp. · Class I
- TALONNETTE FEET PAD AVEC INSERT LATERAL T3 (VENDU PAR PAIRE) — Orliman, S.L.U. · Class I
- ESTCARBON — Erismet OU · Class I
- BA 702-26 — BİOAKTİF TIBBİ ÜRÜNLER VE TEKNİK TEKSTİL SAN. TİC. LTD. ŞTİ. · Class I
- Medisole Forefoot Women size 39 — Dumco B.V. · Class I
- MEDI — MEDI MANUFACTURING, INC. · Class I
- Iloiset Varpaat Varvastuppi S/M — Suomen Hoitolatukku Tuonti Oy · Class I
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 | 84351355LUNAGELWA | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laboratorios Herbitas, S.l.
- EUDAMED SRN
- ES-MF-000004599
Sources (3)
- EUDAMED 6c8759b3-3f87-4aae-9cf0-eed34ae2034a 61 fields · synced Jul 20, 2026
- EUDAMED 72034f86-05ea-41ea-986d-f6b53d69fd00 61 fields · synced May 18, 2026
- EUDAMED d19f5bf5-b021-4b45-85ed-df281ed6fab6 61 fields · synced May 18, 2026