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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

JCR000 — Class IIa MDD by LABIALFARMA –…

MD Atlas
LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.

EUDAMED last updated this device on Sep 15, 2023

JCR000

B-PTMF000003551JCR0005L

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
UDI-DI code: D-PTMF000003551JCR0005L
Reference / catalog number: JCR000

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View device family (Basic UDI)

Manufacturer information

Organization name: LABIALFARMA – LABORATÓRIO DE PRODUTOS FARMACÊUTICOS E NUTRACÊUTICOS, S.A.
SRN: PT-MF-000003551
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW999
Warnings: Do not swallow. Do not use on damaged skin. Do not use on torn muscles. Do not use on post-surgery wounds. Do not use in case of hypersensitivity or allergy to any of the components. Avoid contact with eyes and mucous membranes. In case of pregnancy and/or lactation, you should consult your doctor or pharmacist before using this medical device. Treatment should be discontinued in case of skin rash or any other sign of hypersensitivity. Recommended and optimal usage time is 7 days. If symptoms persist after this period, consult your doctor or pharmacist. Do not use after the expiry date stated on the label. Do not use for more than 12 months after first use. EXTERNAL USE ONLY.
CW999
Contra-indications: - In children under 12 years old; - On damaged skin, torn muscles or post-surgery wounds; - In patients who suffer from allergy or hypersensitivity reactions to any of the components; - Without medical advice, if pregnant or breastfeeding.

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Market distribution

Primary placement in Portugal; available across 1 country total.

Country	On market since	Until
PortugalPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-PTMF000003551JCR0005L
Basic UDI-DI: B-PTMF000003551JCR0005L
Reference / catalog number: JCR000
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Joints Cream is a galenic preparation (cream) for topical use, not subject to medical prescription. The formulation contains cetylated fatty acids to support the mechanical effect of the massage and also menthol, to achieve a cryotherapy effect. The cream is provided in an 80 mL tube, in an 100 mL tube and in a 200 mL tube.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-PTMF000003551JCR0005L

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M9099GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102)

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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